July/August 2014

July/August 2014 Drug Information Update Copyright© PerformRx, LLC 2013 All Rights Reserved 1 DRUG INFORMATION UPDATE Table of Contents NEW GENERICS TO MARKET ................................................................................................................ 3 NEW DRUG ENTITIES ............................................................................................................................ 4 NEW INDICATIONS (EXISTING DRUGS) ................................................................................................ 8 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ...................................................................... 10 STUDIES ............................................................................................................................................... 20 RECALLS ............................................................................................................................................... 45 CURRENT DRUG SHORTAGES ............................................................................................................. 86 NEW DRUGS COMING TO MARKET .................................................................................................191 Copyright© PerformRx, LLC 2013 All Rights Reserved 2 NEW GENERICS TO MARKET GENERIC DRUG NAME Testosterone Methoxsalen Urea Prenatal Vit #86/Fe, FA, Choline, DHA, Ca Valsartan PNV with Ca, No.70/Iron/FA/DHA Levomefolate/Algal Oil B3/Azel/Quer/Tur/FA/B6/Zn/Cop p Topiramate Fenoprofen Calcium Ropivacaine HCl Ropivacaine HCl (PF) Amoxicillin STRENGTH & DOSAGE FORM 1.25gm (1%) gel pump 50mg (1%) gel packet 10mg cap 35% foam 32mg-1mg tab GENERIC MANUFACTURER Upsher Smith BRAND NAME APPROVAL DATE Vogelxo 06/17/14 Strides Acella Prugen Oxsoralen-Ultra Hydro 35 Nestabs 06/24/14 05/12/10 06/20/14 40mg, 80mg, 160mg, 320mg tabs 28-1-250mg cap 15-90.314, 7.590.314mg 700-500mg Sandoz Diovan 07/08/14 Virtus Zerxis Natelle One Deplin-Algal Oil 07/10/14 03/13/13 Virtus NicAzel Forte 07/10/14 25mg, 50mg, 100mg, 150mg, 200mg ER cap 400mg cap 10mg/mL vial 5mg/mL vial (PF) 775mg ER tab Upsher Smith Qudexy XR 07/09/14 KLE 2, Inc. Sandoz Nalfon Naropin 07/17/14 07/24/14 Perrigo Moxatag 08/12/14 Copyright© PerformRx, LLC 2013 All Rights Reserved 3 NEW DRUG ENTITIES DESCRIPTION PEDIATRIC VITAMIN PREPARATIONS PEDIATRIC VITAMIN PREPARATIONS BRAND NAME COMPLETE FORMULATION PEDIATRIC COMPLETE FORMULATION D3000 GENERIC NAME STRENGTH NOTES PEDI MULTIVIT #77/VIT D3/VIT K 750-500/.5 New Combination PEDIATRIC VITAMIN PREPARATIONS ESCAVITE D PEDI MULTIVIT #78/IRON/FLUORID 6MG-0.25MG New Combination New Combination LIPOGLYCOPEPTIDE ANTIBIOTIC DALVANCE DALBAVANCIN HCL 500 MG New Entity DIETARY SUPPLEMENT, MISCELLANEOUS APPTRIM CAFF/CHOLINE/AA COMB.NO7/HC125 40.5-101MG New Combination DIETARY SUPPLEMENT, MISCELLANEOUS THERAMINE PLUS CHOL/AA10/GABA/HERB129/PR T/LEC 62.5-100-9 New Combination CYCLOPHOSPHAMIDE 25 MG CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50 MG SUTENT SUNITINIB MALATE 37.5 MG New Strength TEDIZOLID PHOSPHATE 200 MG (IV) New Entity TEDIZOLID PHOSPHATE 200 MG (PO) ANTINEOPLASTIC – ALKYLATING AGENTS ANTINEOPLASTIC – ALKYLATING AGENTS ANTINEOPLASTIC – SYSTEMIC ENZYME INHIBITORS CYCLOPHOSPHAMIDE OXAZOLIDINONES SIVEXTRO OXAZOLIDINONES SIVEXTRO ANTIVIRALS, HIV-1 INTEGRASE STRAND TRANSFER INHIBITOR DIETARY SUPPLEMENT, MISCELLANEOUS PRENATAL VITAMIN PREPARATIONS PRENATAL VITAMIN PREPARATIONS ISENTRESS APPTRIM-D PRENATE STAR PRENATE DHA ACNE AGENTS, TOPICAL NEUAC PLASMA PROTEINS ATRYN INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES NUTRITIONAL THERAPY, MED COND SPECIAL PEDI MULTIVIT #61/VIT D3/VIT K RALTEGRAVIR POTASSIUM CHOLINE BIT/AA COMB.NO7/HC125 PRENATAL NO.77/IRON ASP GLY/FA PNV #78/IRON ASP GLY/FA#1/DHA CLINDAMYCIN/BENZOYL/EMOL CMB94 ANTITHROMBIN III, HUMAN RECOMB FLUCELVAX 2014-2015 FLU VACC TS 14-15 (18+)CELL/PF FLUZONE HIGH-DOSE 2014-2015 FLU VACC TS 2014-15 (65YR+)/PF NUTRITIONAL TX, KETOGENIC/LCT CARBZERO Copyright© PerformRx, LLC 2013 All Rights Reserved 3000-800 100 MG 101 MG 20 MG-1 MG 18-1-300MG 1.2(1)%-5% New Dosage Form New Dosage Form New Entity New Dosage Form New Combination New Combination New Combination New Combination 525 UNIT New Strength 45MCG/.5ML New Entity 180MCG/0.5 New Entity 20 G-180 New Combination and 4 DESCRIPTION FORMULATION NUTRITIONAL THERAPY, MED COND SPECIAL FORMULATION PRENATAL VITAMIN PREPARATIONS VITAMIN B12 PREPARATIONS ANTISEBORRHEIC AGENTS ANTIHEMOPHILIC FACTORS ANTIHEMOPHILIC FACTORS ANTIHEMOPHILIC FACTORS ANTIHEMOPHILIC FACTORS ANTIHEMOPHILIC FACTORS ANTIHEMOPHILIC FACTORS ANTIHEMOPHILIC FACTORS TOPICAL LOCAL ANESTHETICS TOPICAL ANTIINFLAMMATORY STEROIDAL TOPICAL ANTIBIOTIC & ANTI-INFLAMMATORY STEROID TOPICAL ANTIBIOTIC & ANTI-INFLAMMATORY STEROID INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS BRAND NAME GENERIC NAME STRENGTH NOTES NASCOBAL PRENATAL #79/IRON ASP GLY/FA#1 CYANOCOBALAMIN (VITAMIN B12) 500MCG/SPR Dosage Form New Combination and Dosage Form New Delivery Device New Dosage Form OVACE PLUS SULFACETAMIDE SODIUM 9.80% New Entity 250 UNIT New Entity 500 UNIT New Entity 750 UNIT New Entity 1000 UNIT New Entity 1500 UNIT New Entity 2000 UNIT New Entity BETAQUIK PRENATE ELITE ELOCTATE ELOCTATE ELOCTATE ELOCTATE ELOCTATE ELOCTATE ELOCTATE VEXA NUTRITIONAL TX, KETOGENIC/MCT FACTOR VIII REC,FC FUSION PROT FACTOR VIII REC,FC FUSION PROT FACTOR VIII REC,FC FUSION PROT FACTOR VIII REC,FC FUSION PROT FACTOR VIII REC,FC FUSION PROT FACTOR VIII REC,FC FUSION PROT FACTOR VIII REC,FC FUSION PROT LIDOCAINE/ALLANTOIN/PETROL ATUM 21 G-189 20 MG-1 MG 3000 UNIT New Entity 4%-2%-30 % New Combination CLODAN CLOBETASOL/SKIN CLEANSER #28 0.05% New Combination NEO-SYNALAR NEOMYCIN/FLUOCINOLONE/EM OL #65 0.5-0.025% New Combination NEO-SYNALAR NEOMYCIN SULFATE/FLUOCINOLONE 0.5-0.025% New Combination FLU VACC TS 2014 (1864YRS)/PF FLU VACCINE QS 201415(6MOS+) FLU VACC QS 201415(36MOS+)/PF FLU VACC QS 201415(36MOS+)/PF FLU VACC TS 201415(36MOS+)/PF FLU VACCINE TS201415(4YR+)/PF FLU VACCINE TS 2014-15 (4 YR+) 27MCG/.1ML (SYR) 60MCG/.5ML (VIAL) 60MCG/.5ML (SYR) 60MCG/.5ML (VIAL) 45MCG/.5ML (SYR) 45MCG/.5ML (SYR) 45MCG/.5ML FLUZONE INTRADERMAL 2014-2015 FLUZONE QUAD 20142015 FLUZONE QUAD 20142015 FLUZONE QUAD 20142015 FLUZONE 2014-2015 FLUVIRIN 2014-2015 FLUVIRIN 2014-2015 Copyright© PerformRx, LLC 2013 All Rights Reserved New Entity New Entity New Entity New Entity New Entity New Entity New Entity 5 DESCRIPTION VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES ANTIHYPERGLY,INCRETI N MIMETIC(GLP-1 RECEP.AGONIST) PRENATAL VITAMIN PREPARATIONS ANTIDIARRHEAL MICROORGANISMS AGENTS ANTINEOPLAST,HISTON E DEACETYLASE (HDAC) INHIBITORS BRAND NAME GENERIC NAME STRENGTH FLUZONE QUAD PEDI 2014-2015 FLUMIST QUAD 20142015 FLU VACCINE TS 2014-15(6 MOS+) FLU VACCINE 2014(635MOS)/PF FLU VACC QV LIVE 2014(249YRS) (VIAL) 45MCG/.5ML (VIAL) 30MCG/0.25 (SYR) 10E6.5-7.5 (NAS SP SYR) BYDUREON PEN EXENATIDE MICROSPHERES 2MG/0.65ML New Strength and Dosage Form FOLET ONE PNV NO.80/IRON/ MFOLATE/DSS/DHA 38-1-25 MG New Combination RESTORA RX LACTOBACILLUS CASEI/FOLIC ACID 60-1.25 MG New Combination BELEODAQ BELINOSTAT 500 MG New Entity 0.033 % New Entity FLUZONE 2014-2015 SODIUM CHLOR/HYPOCHLOROUS ACID IRON/MFOLATE/B12/C/BIOT/ZN /DSS NOTES New Entity New Entity New Entity IRRIGANTS VASHE WOUND THERAPY IRON REPLACEMENT MAXFE KERATOLYTICS UREA UREA 40 % BUNAVAIL BUPRENORPHINE HCL/NALOXONE HCL 2.1-0.3 MG New Strength and Route BUNAVAIL BUPRENORPHINE HCL/NALOXONE HCL 4.2-0.7 MG New Strength and Route BUNAVAIL BUPRENORPHINE HCL/NALOXONE HCL 6.3MG-1MG New Strength and Route JARDIANCE EMPAGLIFLOZIN 10 MG New Entity JARDIANCE EMPAGLIFLOZIN 25 MG New Entity QUFLORA PEDI MV NO.83 WITH FLUORIDE 0.25 MG/ML QUFLORA PEDI MV NO.83 WITH FLUORIDE 0.5 MG/ML NARCOTIC WITHDRAWAL THERAPY AGENTS NARCOTIC WITHDRAWAL THERAPY AGENTS NARCOTIC WITHDRAWAL THERAPY AGENTS ANTIHYPERGLYCEMCSOD/GLUC COTRANSPORT2(SGLT2) INHIB ANTIHYPERGLYCEMCSOD/GLUC COTRANSPORT2(SGLT2) INHIB PEDIATRIC VITAMIN PREPARATIONS PEDIATRIC VITAMIN PREPARATIONS SKIN TISSUE REPLACEMENT SKIN TISSUE REPLACEMENT GRAFIX CORE GRAFIX PRIME HUMAN REGENERATIVE TISSUE MTRX HUMAN REGENERATIVE TISSUE MTRX Copyright© PerformRx, LLC 2013 All Rights Reserved 160MG-1-60 New Combination New Formulation LOTION (GM) New Combination New Combination 1.5CMX2CM New Strength 3 CMX 4 CM New Strength 6 DESCRIPTION BRAND NAME GENERIC NAME STRENGTH TETRACYCLINES ACTICLATE DOXYCYCLINE HYCLATE 75 MG TETRACYCLINES ACTICLATE DOXYCYCLINE HYCLATE 150 MG AFLURIA 2014-2015 FLU VACCINE TS 2014-15 (5 YR+) AFLURIA 2014-2015 FLU VACCINE TS201415(5YR+)/PF 45MCG/.5ML ZINC GLUCONATE ZINC GLUCONATE 1 MG/ML New Strength, Route and Dosage Form INVOKAMET CANAGLIFLOZIN/METFORMIN HCL 50-1000 MG New Combination INVOKAMET CANAGLIFLOZIN/METFORMIN HCL 150-1000MG New Combination INVOKAMET CANAGLIFLOZIN/METFORMIN HCL 150-500MG New Combination INVOKAMET CANAGLIFLOZIN/METFORMIN HCL 50MG-500MG New Combination CITRANATAL RX PNV NO.81/IRON CBN&GLUC/FA/DSS 27-1-50 MG New Combination NORTHERA DROXIDOPA 100 MG New Entity NORTHERA DROXIDOPA 200 MG New Entity NORTHERA DROXIDOPA 300 MG New Entity APOP SULFACETAMIDE SODIUM/BAKUCHIOL 10%-0.5% New Combination INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES ZINC REPLACEMENT ANTIHYPERGLYCEMICSGLT2 INHIBITOR & BIGUANIDE COMB ANTIHYPERGLYCEMICSGLT2 INHIBITOR & BIGUANIDE COMB ANTIHYPERGLYCEMICSGLT2 INHIBITOR & BIGUANIDE COMB ANTIHYPERGLYCEMICSGLT2 INHIBITOR & BIGUANIDE COMB PRENATAL VITAMIN PREPARATIONS ADRENERGIC VASOPRESSOR AGENTS ADRENERGIC VASOPRESSOR AGENTS ADRENERGIC VASOPRESSOR AGENTS ACNE AGENTS,TOPICAL Copyright© PerformRx, LLC 2013 All Rights Reserved 45MCG/.5ML NOTES New Dosage Form New Dosage Form New Entity New Entity 7 NEW INDICATIONS (EXISTING DRUGS) NOVOSEVEN® July 7, 2014 FDA Approves NovoSeven® RT for the Treatment of Glanzmann's Thrombasthenia (GT) With Refractoriness First Recombinant Treatment Approved in US for Patients With GT With Refractoriness to Platelet Transfusions, With or Without Antibodies to Platelets PLAINSBORO, N.J., July 7, 2014 /PRNewswire/ -- Novo Nordisk today announced the US Food and Drug Administration (FDA) has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) as the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann's Thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets. Glanzmann's Thrombasthenia is a rare genetic bleeding disorder with limited treatment options. The safety and effectiveness of NovoSeven® RT were demonstrated in the treatment of severe bleeding episodes and the perioperative management for major and minor surgical procedures for this specific patient population. Article link:http://press.novonordisk-us.com/2014-07-07-FDA-Approves-NovoSeven-RT-fortheTreatment-of-Glanzmanns-Thrombasthenia-GT-With-Refractoriness Source website:http://press.novonordisk-us.com/ IMBRUVICA® July 28, 2014 U.S. FDA Grants Regular (Full) Approval for IMBRUVICA® for Two Indications Jul 28, 2014 Previously Treated Chronic Lymphocytic Leukemia (CLL) Based on Statistically Significant Progression-Free and Overall Survival Benefits Del 17P CLL, Only FDA-Approved Agent Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has granted IMBRUVICA® (ibrutinib) regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients. Article link: http://ir.pharmacyclics.com/releasedetail.cfm?ReleaseID=862371 Copyright© PerformRx, LLC 2013 All Rights Reserved 8 Source website:http://ir.pharmacyclics.com/ EYLEA® July 29, 2014 EYLEA® (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME) DME is the third approved indication for EYLEA in the U.S. TARRYTOWN, N.Y., July 29, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced thatthe U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection for the treatment of Diabetic MacularEdema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks. Article link: http://files.shareholder.com/downloads/REGN/ 3365699376x0x772028/698a12f7-a8dc-4f89-b9e2f8134ae6f3de/REGN_News_2014_7_29_General_Releases.pdf Source website: http://files.shareholder.com/ LUMIZYME® August 1, 2014 Lumizyme® Genzyme Receives Label Expansion for Lumizyme® (alglucosidase alfa) in the United States for the treatment of Pompe Disease August 1, 2014 - CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced that the U.S. Food and Drug Administration (FDA) approved a supplement to expand the indication for Lumizyme® (alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated for all Pompe patients of any age or phenotype. The approval of this indication is now consistent with that of the rest of the world, where alglucosidase alfa manufactured at the 4000L is the only scale available. Previously, in the United States, Lumizyme had been approved only for patients with late onset Pompe disease. Copyright© PerformRx, LLC 2013 All Rights Reserved 9 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error June 11, 2014 ISSUE: Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMBBA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with. In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is recalling the test strips in an effort to avoid confusion and the possible misuse of the Advocate Redi-Code+blood glucose test strips with the Taidoc meters listed in the Firm Press Release, which could result in incorrect glucose results. Falsely high or falsely low glucose results could potentially cause missed or delayed hyperglycemia or hypoglycemia detection and lead to no treatment or inappropriate treatment. Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states could lead to serious health consequences, including death. BACKGROUND: Diabetic Supply of Suncoast, Inc. is notifying its wholesale Distributors, Pharmacies, Medical Supply stores, Health Care Providers and direct customers throughout the entire US and Virgin Islands by letter and Press Release about the specifics of the recall. RECOMMENDATION: Customers who have the affected test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information. Test strips will be replaced with relabeled boxes of test strips to avoid any chance of confusion. Consumers should stop using the above mentioned test strips and contact Suncoast to find out if this recall pertains to the test strips they have in their possession and if so how to have them replaced for the relabeled products manufactured by BroadMaster Bio-Tech. Customers with questions may contact Diabetic Supply of Suncoast at (561) 296-0488 between the hours of 9:00AM and 5:00PM Monday through Friday Eastern standard time or view the information at www.dsosi.com. Customers who have the Advocate Redi-Code blood glucose meters manufactured by Taidoc Technology Corp should follow the product User Manual for information about the appropriate test strips to be used with the Taidoc meters. Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm400668.htm Source website: http://www.fda.gov/ Copyright© PerformRx, LLC 2013 All Rights Reserved 10 Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication June 20, 2014 ISSUE: FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk. BACKGROUND: Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer. RECOMMENDATION: Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm •Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm402106.htm Source website: http://www.fda.gov/ Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots 06/20/2014 ISSUE: FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). BACKGROUND: The risk of venous blood clots as a possible consequence of polycythemia is already included in the labeling of testosterone products. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots, to ensure this risk is described consistently in the labeling of all approved testosterone products. Copyright© PerformRx, LLC 2013 All Rights Reserved 11 RECOMMENDATION: Note - This new warning, a class labeling change, is not related to an ongoing FDA evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. FDA is currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in a January 31, 2014 MedWatch Safety Alert. Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm402054.htm Source website: http://www.fda.gov/ Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain June 26, 2014 ISSUE: FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death. Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying. BACKGROUND: In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. See further details in the FDA Drug Safety Communication. RECOMMENDATION: Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain. • Use a teething ring chilled in the refrigerator (not frozen). • Gently rub or massage the child’s gums with your finger to relieve the symptoms. FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because some of them can be harmful. FDA recommends following the American Academy of Pediatrics’ recommendations to help lessen teething pain. Copyright© PerformRx, LLC 2013 All Rights Reserved 12 Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm402790.htm Source website: http://www.fda.gov/ Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved June 30, 2014 ISSUE: FDA alerted health care professionals not to use injectable vitamin drug products distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the label. These products are manufactured by Compound Brothers Dominicana (also known as CB Inc.) in the Dominican Republic and sold as prescription injectable nutritional supplements. FDA has not approved these products and cannot be assured of their safety, effectiveness, or quality. All lots of non-expired products from Compound Brothers Inc. and labeled as Sunshine Labs are being recalled by Medical Supply Liquidators. See the FDA Statement for a listing of all affected products. RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm403435.htm Source website: http://www.fda.gov/ FDA outlines expectations for human drug compounders, including registered outsourcing facilities July 1, 2014 Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists. Article link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm403507.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery Source website: http://www.fda.gov/ Copyright© PerformRx, LLC 2013 All Rights Reserved 13 Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination July 11, 2014 ISSUE: Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiry 1NOV2015 . This action is due to one confirmed customer report where particulate was identified within the solution of the primary container. The particulate was identified as a filamentous-like structured particulate indicative of mold. Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak. Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure. Hospira has not received reports of any adverse events associated with this issue for this lot to date, and has not identified any quality issues with retention samples for this lot. BACKGROUND: The product is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container. This lot was distributed nationwide from December 2013 through February 2014 and was distributed to hospitals, clinics, wholesalers and distributors. RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product. Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm404667.htm Source website: http://www.fda.gov/ Copyright© PerformRx, LLC 2013 All Rights Reserved 14 The MedWatch June 2014 Safety Labeling Changes posting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. July 15, 2014 The "Summary Page" provides a listing of product names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/ SafetyInformation/ucm402776.htm The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections: Alsuma (sumatriptan) Androderm (testosterone) AndroGel (testosterone) gel Avalide (irbesartan and hydrochlorothiazide) Aveed (testosterone undecanoate) Axiron (testosterone) Benicar (olmesartan medoxomil) Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) Caverject (alprostadil for injection) Caverject Impulse Dual Chamber System (alprostadil for injection) Cerebyx (Fosphenytoin Sodium Injection) Cleocin Phosphate (Clindamycin injection, USP) and (clindamycin injection in 5 percent dextrose) Cleocin HCL (clindamycin hydrochloride) Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) Comtan (entacapone) Delatestryl (testosterone enanthate) Ella (ulipristal acetate) Fortesta (testosterone) gel Gazyva (obinutuzumab) Herceptin (trastuzumab) Hycamtin (topotecan) Jetrea (ocriplasmin) Lupron Depot (leuprolide acetate) Nutropin AQ (somatropin [rDNA origin]) Prolia (denosumab) Ravicti (glycerol phenylbutyrate) Saizen (somatropin [rDNA origin]) Serostim (somatropin [rDNA origin] for injection) Sporanox (itraconazole) Copyright© PerformRx, LLC 2013 All Rights Reserved 15 Striant (testosterone) Sutent (sunitinib malate) Symlin (pramlintide acetate) Testim (testosterone) Testosterone gel Tev-Tropin (somatropin [rDNA origin]) Thalomid (thalidomide) Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Trileptal (oxcarbazepine) Votrient (pazopanib) Xgeva (denosumab) Zestril (lisinopril) Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm402776.htm Source website: http://www.fda.gov/ Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall Mislabeled Packaging 07/21/2014 ISSUE: American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated BACKGROUND: Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy. Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084703-11, Lot #142588, Expiration Date, 01/2016. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with “IP 465” printed on one side. Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-14311, Lot #142544, Expiration Date, 02/2016. The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '184' on one side and scored on other side. Copyright© PerformRx, LLC 2013 All Rights Reserved 16 These hospital unit dose products were distributed nationwide beginning June 20, 2014. RECOMMENDATION: Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers. Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product. For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST. Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm406124.htm Source website: http://www.fda.gov/ Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates July 30, 2014 ISSUE: Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. If the particulate goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. Particulates may be able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage. BACKGROUND: Lidocaine is packaged 10 units per carton / 180 units per case in singledose glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 2013. RECOMMENDATION: Anyone with existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira is notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for return processing. For additional assistance, call Stericycle at1-855-827-6586 (M-F, 8 a.m. - 5 p.m. ET). For clinical inquiries, refer to the Firm Copyright© PerformRx, LLC 2013 All Rights Reserved 17 Press Release. Article link: http://www.fda.gov/Safety/MedWatch/ SafetyInformation/ucm402776.htm Source website: http://www.fda.gov/ FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements August 1, 2014 The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated. Pompe disease is a rare genetic disorder and occurs in an estimated 1 in every 40,000 to 300,000 births. Its primary symptom is heart and skeletal muscle weakness, progressing to respiratory weakness and death from respiratory failure. The disease causes gene mutations to prevent the body from making enough of the functional form of an enzyme called acid alpha-glucosidase (GAA). This enzyme is necessary for proper muscle functioning. GAA is used by the heart and muscle cells to convert a form of sugar called glycogen into energy. Without the enzyme action, glycogen builds up in the cells and, ultimately, weakens the heart and muscles. Lumizyme is believed to work by replacing the deficient GAA, thereby reducing the accumulated glycogen in heart and skeletal muscle cells. Source: U.S. Food and Drug Administration (FDA) CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall Foreign Particulate Matter 08/09/2014 ISSUE: Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. Refer to the Press Release for a list of affected products. The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots. Copyright© PerformRx, LLC 2013 All Rights Reserved 18 BACKGROUND: CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. CUBICIN was distributed Nationwide to multiple consignees. RECOMMENDATION: Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of these recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots. Source: U.S. Food and Drug Administration (FDA) Copyright© PerformRx, LLC 2013 All Rights Reserved 19 STUDIES and RECENT TOPICS Prescription Overdose Deaths in Florida Plunge After Tougher Measures, Report Says July 1, 2014 Prescription drug overdose deaths in Florida fell sharply after the state began strengthening its prescribing laws and stepping up enforcement. Federal researchers said Tuesday that it was the first significant documented decline in the nation since the epidemic of prescription drug abuse took hold more than a decade ago. Article link: http://www.nytimes.com/2014/07/02/health/prescription-drug-deaths-infloridaplungeafter-tougher-laws.html?partner=rss&emc=rss&_r=1 Source website: http://www.nytimes.com/ Painkiller prescription rates vary widely among states July 1, 2014 U.S. health care providers wrote 259 million prescriptions for opioid painkillers in 2012, enough to give a bottle of the pills to every adult in the country. But your chances of ending up with those pills – and the risks that come with them – depend a lot on where you live, says a new report from the federal Centers for Disease Control and Prevention. Article link: http://www.usatoday.com/story/news/nation/2014/07/01/painkillerprescriptionratesstates/11898327/ Source website: http://www.usatoday.com/ FDA tightens oversight of pharmacies July 1, 2014 The Food and Drug Administration is beefing up its oversight of pharmacies that create custom drugs in response to a 2012 meningitis outbreak linked to tainted medicines that left 64 people dead. The FDA released regulations Tuesday for compounding pharmacies, which work with physicians to create specific drugs for individual patients, rather than mass producing pharmaceuticals for the public. Article link: http://thehill.com/policy/healthcare/211060-fda-tightens-oversight-of-pharmacies Source website: http://thehill.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 20 Roche to Cochrane: Critical Tamiflu study made 'fundamental mistakes' July 1, 2014 Back in April, a study conducted by the nonprofit Cochrane Group suggested that the $2 billion worth of Roche's ($RHHBY) Tamiflu and other flu fighters stockpiled by the U.S. and the U.K. to protect against a pandemic has essentially amounted to money thrown down the drain. Now Roche is fighting back, claiming the Cochrane researchers, whose paper was published in the British Medical Journal, failed to include all the relevant data, and furthermore didn't seem to understand how Tamiflu works. The BMJ recently posted Roche's response to the study on its website. Article link: http://www.fiercepharma.com/story/roche-cochrane-critical-tamiflu-studymadefundamentalmistakes/2014-07-01 Source website: http://www.fiercepharma.com/ What’s in a Name? FDA Urged Not to Give Biosimilars Unique Names. July 2, 2014 When a biosimilar version of the Avastin cancer treatment becomes available, what should it be called? The chemical name is bevacizumab, and this is often used by physicians and pharmacists when they discuss the drug. But whether such generic nomenclatures should also become widely used commercial monikers is the subject of an ongoing controversy among drug makers and their major customers. Article link:http://blogs.wsj.com/pharmalot/2014/07/02/whats-in-a-name-fda-urged-nottogivebiosimilars-unique-names/ Source website: http://blogs.wsj.com/ Sitagliptin Linked to Higher HF Hospitalization Risk July 2, 2014 In patients with type 2 diabetes and heart failure, the use of sitagliptin (Januvia) was associated with greater risk of hospitalization for heart failure, a study based on insurance claims showed. Article link: http://www.medpagetoday.com/Cardiology/Diabetes/46602 Source website: http://www.medpagetoday.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 21 Testosterone therapy showed no increased risk for MI in older men July 2, 2014 A national sample of men older than 65 years showed no increased risk for myocardial infarction in those who were prescribed testosterone therapy as compared with nonusers, according to study data published today. Article link: http://www.healio.com/endocrinology/hormonetherapy/ news/online/%7B35b2c02e-571a-4758-b307-401b0965065c%7D/testosteronetherapyshowed-no-increased-risk-for-mi-in-older-men Source website: http://www.healio.com/ Roche biotech drug offers new way to fight asthma July 2, 2014 An experimental antibody drug from Roche has produced promising results in mid-stage tests for asthma, offering a new way to fight the breathing disorder. The encouraging response seen with quilizumab, which the Swiss group is developing as a treatment for moderate-to-severe asthma, underscores the growing focus on novel biotech medicines for hard-to-treat cases of the disease. Article link: http://www.reuters.com/article/2014/07/02/rocheasthmaidUSL6N0PD3V520140702 Source website: http://www.reuters.com/ FDA's Looming Decision On A Generic To Teva's Copaxone Reveals Drug Approval Woes July 7, 2014 A year ago, the Food and Drug Administration quietly posted a public notice that it wanted to hire an independent lab to test a generic drug that it had already approved. FDA wanted to make sure the drug was safe and effective. Article link: http://www.forbes.com/sites/scottgottlieb/2014/07/07/fdas-looming-decisionongenericcopaxone-from-teva-reveals-drug-approval-woes/?ss=pharma Source website: http://www.forbes.com/ Novartis cell treatment named "Breakthrough Therapy" in US July 7 2014 Swiss drugmaker Novartis said on Monday U.S. health regulators have granted its personalised cell therapy CLT019 "Breakthrough Therapy" status, meaning the treatment will be fast-tracked within the U.S. regulatory system. Article link: http://in.reuters.com/article/2014/07/07/novartis-drug-idINL6N0PI4W720140707 Source website: http://in.reuters.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 22 BioDelivery, Endo painkiller moves one step closer to approval July 7 2014 Endo International Plc and BioDelivery Sciences International Inc said their experimental pain drug was found effective in a second late-stage trial, taking the drug a step closer to a marketing approval. BioDelivery's shares jumped as much as 20 percent to a new life-high, while Endo was down 1.7 percent on Monday morning. Article link: http://www.reuters.com/article/2014/07/07/endo-intlstudyidUSL4N0PI2XU20140707 Source website: http://www.reuters.com/ Obesity May Raise Risk of COPD July 7, 2014 Obese people, particularly those with excess belly fat, may face a higher risk of developing chronic obstructive pulmonary disease (COPD), a new study suggests.The researchers report that women with a waist size of roughly 43 inches or more and men with waist size of 46 inches or more showed a 72 percent increased risk of developing the lung disease, compared with people who had a normal waist size. Article link: http://consumer.healthday.com/vitamins-and-nutrition-information27/obesityhealthnews-505/obesity-linked-with-copd-risk-689538.html Source website: http://consumer.healthday.com/ Scientists Are Getting Closer to a Blood Test for Alzheimer’s July 8, 2014 A team of scientists have identified 10 proteins in the blood that can predict the onset of Alzheimer’s disease. The study, which was published in the journal Alzheimer’s & Dementia, looked at more than 1,000 people and is considered a significant step toward the development of a blood test for Alzheimer’s. The trouble with the disease is that developing drug treatments is difficult since they are often given in clinical trials when the disease has already progressed too far. The hope is that identifying the disease earlier could pave the way for drugs to halt its progression. Article link: http://time.com/2963692/alzheimers-disease-blood-test/ Source website: http://time.com/ Sanofi's (SNY) NDA for Toujeo Accepted for Review by U.S. FDA July 8, 2014 Sanofi (NYSE: SNY) said that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] Copyright© PerformRx, LLC 2013 All Rights Reserved 23 injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27, 2014. Article link: http://www.streetinsider.com/Corporate+News/Sanofis+(SNY)+NDA+for+ Toujeo+Accepted+for+Review+by+U.S.+FDA/9643953.html Source website: http://www.streetinsider.com/ Rapid Price Increases for Some Generic Drugs Catch Users by Surprise July 8, 2014 The first sign of trouble came when Dr. Barry Lindenberg, a cardiologist, received a threepage insurance form in January, demanding he get preapproval to prescribe one of the oldest known heart medicines. His patient had been on the drug, digoxin, for many years. A mainstay of treating older patients with rapid rhythm disturbances, it was first described in the medical literature in 1785. Millions of Americans still use it every day, and many had long paid just pennies a pill. Article link: http://www.nytimes.com/2014/07/09/health /some-generic-drug-pricesaresoaring. html?hp&action=click&pgtype=Homepage&version= HpSumSmal lMediaHigh&module=second-column-region&region=top-news&WT.nav=top-news&_r=0 Source website: http://www.nytimes.com/ Study: Psych drug ER trips approach 90,000 a year July 9, 2014 Bad reactions to psychiatric drugs result in nearly 90,000 emergency room visits each year by U.S. adults, with anti-anxiety medicines and sedatives among the most common culprits, a study suggests. A drug used in some popular sleeping pills was among the most commonly involved sedatives, especially in adults aged 65 and older. Article link: http://hosted.ap.org/dynamic/stories/U/US_MED_PSYCH_DRUG_EMERGENCIES? SITE= AP&SECTION=HOME&TEMPLATE=DEFAULT Source website: http://hosted.ap.org/ FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules July 9, 2014 Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels? Copyright© PerformRx, LLC 2013 All Rights Reserved 24 Article link: http://www.washingtonpost.com/national/healthscience/2014/07/09/3708dd6afbc411e3-8176-f2c941cf35f1_story.html Source website: http://www.washingtonpost.com/ Sanofi Plans Final Tests as Regeneron Drug Cuts Eczema Symptoms July 9, 2014 Sanofi (SAN) and Regeneron Pharmaceuticals (REGN) said they plan to test their experimental eczema treatment in large late-stage studies after a smaller trial reduced symptoms of the scaly, itching disease. Article link: http://www.bloomberg.com/news/2014-07-09/sanofi-plans-final-testsasregenerondrug-cuts-eczema-symptoms.html Source website: http://www.bloomberg.com/ Breast Cancer Drug May Help Women Fight a Leading Cause of Infertility: Study July 9, 2014 Letrozole improves pregnancy rates in women with polycystic ovary syndrome, researcher says Women with polycystic ovary syndrome have a better chance of getting pregnant if they take a breast cancer drug instead of the currently preferred medication, a new study suggests. Article link: http://consumer.healthday.com/diseases-and-conditions-information37/miscdiseasesand-conditions-news-203/breast-cancer-drug-help-fight-common-cause-ofinfertilitystudy-finds-689619.html Source website: http://consumer.healthday.com/ FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant July 10, 2014 A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect. Article link: http://www.forbes.com/sites/larryhusten/2014/07/10/fda-places-clinical-holdonphase3-trial-of-novel-anticoagulant/ Source website: http://www.forbes.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 25 Study finds alarming global rise in use of antibiotics July 10, 2014 Antibiotic use has surged by 36% worldwide in a decade, much of it unwarranted, according to a new study. The rise, particularly in countries with a burgeoning middle class, heightens concerns that overuse of antibiotics is leaving more of the world's population vulnerable to drug-resistant bacteria, according to the authors of the analysis, published online Thursday in the journal Lancet Infectious Diseases. Article link: http://www.latimes.com/science/sciencenow/la-sci-sn-global-rise-antibiotics20140710-story.html# Source website: http://www.latimes.com/ Questcor Reveals Adverse Events Data for Acthar for First Time July 10, 2014 For years, Questcor Pharmaceuticals has highlighted the potential benefits of Acthar, its immune-system drug, while saying little about its ill effects. But according to a regulatory filing made by Questcor early Thursday, the number of patients reporting a so-called adverse event while using the drug last year represented almost 5 percent of prescriptions dispensed. The total number of events in 2013 reported by patients, who can experience multiple ill effects, was almost 14 percent of prescriptions, up from 9.1 percent in 2011. Article link: http://www.nytimes.com/2014/07/11/business/questcor-reveals-adverseeventsdatafor-acthar-for-first-time.html?ref=health&_r=0 Source website: http://www.nytimes.com/ Insurers balk at pricey generic version of ancient GSK heart drug July 10, 2014 The heart drug digoxin--a generic version of GlaxoSmithKline's ($GSK) Lanoxin--used to cost just pennies a pill, making it a prescription that insurance companies were more than happy to cover. Not anymore. The three companies that make generic digoxin have been increasing their prices, causing the cost of the drug to nearly double in the last year. Article link: http://www.fiercepharma.com/story/insurers-balk-pricey-generic-versionancientgskheart-drug/2014-07-10 Source website: http://www.fiercepharma.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 26 India's Sun Pharma recalls over 40,000 bottles of antidepressant July 11, 2014 India's Sun Pharmaceutical Industries is recalling 41,127 bottles of antidepressant venlafaxine hydrochloride in the United States after the drug failed to dissolve properly, the U.S. Food and Drug Administration said. Article link: http://health.yahoo.net/news/s/nm/india-s-sun-pharma-recalls-over-40-000bottles-of-antidepressant Source website: http://health.yahoo.net/ Study calls for more focus on long-term outcomes in pediatric trials of drugs intended for chronic use like in ADHD July 11, 2014 Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children's Hospital report in PLOS ONE. The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process. Article link: http://www.medicalnewstoday.com/releases/279403.php Source website: http://www.medicalnewstoday.com/ Is This MannKind's Greatest Risk? July 11, 2014 Not long ago, some predicted that MannKind (NASDAQ: MNKD ) faced the serious risk of striking out on winning approval for Afrezza. Instead, those predictions swung and missed. The U.S. Food and Drug Administration recently approved the inhaled insulin. Article link: http://www.fool.com/investing/general/2014/07/11/ is-this-mannkindsgreatestrisk. aspx Source website: http://www.fool.com/ FDA Once Again Reaches Conclusions At Odds With Its Own Staff July 14, 2014 Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists. Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug. Copyright© PerformRx, LLC 2013 All Rights Reserved 27 Article link: http://www.forbes.com/sites/larryhusten/2014/07/14/fda-once-againreachesconclusionsat-odds-with-its-own-staff/ Source website: http://www.forbes.com/ Skin gel new ammunition in fight against breast cancer July 14, 2014 A gel containing the drug tamoxifen and applied to the skin was as effective in reducing the growth of breast cancer cells in women with noninvasive cancer as the pill form of the medication — and it caused fewer side effects, according to a new study. Article link: http://wpost.com/national/health-science/skin-gel-new-ammunition-infightagainstbreast-cancer/2014/07/14/f764fb4c-0b6f-11e4-8341-b8072b1e7348_story.html Source website: http://wpost.com/ Don't Judge a Pill by Its Color July 14, 2014 Study finds people may stop taking heart medications if the drug's appearance changes Generic drugs used for heart disease commonly get makeovers that change their shape or color -- and that may prompt some patients to stop using them, a new study finds. Article link:http://consumer.healthday.com/public-health-information-30/drug-safety-news741/when-heart-drugs-change-their-look-people-may-stop-taking-them-689672.html Source website:http://consumer.healthday.com/ FDA Grants Priority Review to New Hep C Combo July 15, 2014 Medivir AB announced that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of once-daily Olysio (simeprevir), in combination with sofosbuvir, for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C. The sNDA was filed in May by Medivir’s strategic partner Janssen Research & Development LLC. Article link: http://www.dddmag.com/news/2014/07/fda-grants-priority-review-new-hepccombo? et_cid=4048933&et_rid=696418053&type=cta Source website: http://www.dddmag.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 28 Niacin Doesn't Reduce Heart Problems, May Create Some, Research Finds July 16, 2014 Niacin, a commonly used cholesterol treatment, doesn't reduce the risk of heart attack or stroke in people with hardened arteries. What's more, the drug appears to have dangerous side effects, including a potential increased risk of death, according to new research. Article link: http://consumer.healthday.com/cardiovascular-health-information-20/miscstrokerelated-heart-news-360/niacin-doesn-t-appear-to-reduce-heart-problems-researchfinds689846.html Source website: http://consumer.healthday.com/ Roche Alzheimer's drug fails main goals in mid-stage study July 16, 2014 Roche's experimental drug crenezumab failed to delay a decline in thinking and memory skills in people with Alzheimer's disease, a result likely to bolster a growing belief that drugs need to be given in earlier stages of the disease to show a benefit. The Swiss drugmaker's treatment was tested in patients with mild-to-moderate forms of Alzheimer's, a fatal, brain-wasting condition that gradually robs patients of their ability to think and care for themselves. Article link: http://www.reuters.com/article/2014/07/16/us-alzheimer-s-rochecrenezumabidUSKBN0FL1Z820140716 Source website: http://www.reuters.com/ 5 Groundbreaking Trials Are Testing Ways to Prevent Alzheimer’s July 16, 2014 Researchers are testing some promising drug candidates to halt Alzheimer’s dementia – even before symptoms startAt the Alzheimer’s Association International Conference in Copenhagen, scientists described five trials that taking the unprecedented step of testing drugs that may prevent the onset of the neurodegenerative disease in people not yet experiencing cognitive decline. Article link: http://time.com/2992603/5-groundbreaking-drugs-that-may-prevent-alzheimers/ Source website: http://time.com/ Antibiotics Often Prescribed Needlessly for Terminally Ill, Study Finds July 16, 2014 Antibiotics are given to many hospice patients, although there's little proof the medicines benefit them, a new study shows. About 21 percent of patients who go directly from hospitals to hospice care for the terminally ill leave the hospital with an antibiotic prescription, even though more than one-quarter didn't have an infection while in the hospital, the researchers found. Copyright© PerformRx, LLC 2013 All Rights Reserved 29 Article link: http://consumer.healthday.com/infectious-disease-information21/antibioticsnews30/antibiotics-often-prescribed-for-terminally-ill-study-finds-689775.html Source website: http://consumer.healthday.com/ AIDS Epidemic May Be Subsiding: Report July 16, 2014 A new United Nations report suggests that the AIDS epidemic might be waning: The number of new HIV infections worldwide is at a record low, AIDS-related deaths are down 35 percent, and more people with HIV are getting the lifesaving medications they need. Article link: http://www.nlm.nih.gov/medlineplus/news/fullstory_147345.html Source website: http://www.nlm.nih.gov/ Flu Drug Fighting Resistant Strains to Seek U.S. Approval July 17, 2014 The first new type of flu drug in more than a decade could seek U.S. regulatory approval as early as next year, aided by U.S. government efforts to combat pandemics and biological threats. Japan’s Fujifilm Holdings Corp. (4901) and partner MediVector Inc. have enrolled more than half the 1,600 patients needed for advanced U.S. studies on the medicine called favipiravir, Kouichi Yamada, senior operations manager of Fujifilm’s pharmaceutical products division said in an interview. They plan to complete the trials around March and file for approvals thereafter. Article link: http://www.bloomberg.com/news/2014-07-17/flu-drug-fighting-resistantstrainsto-seek-u-s-approval.html Source website: http://www.bloomberg.com/ Amgen parathyroid drug found effective in kidney patient trial July 17, 2014 An experimental drug proved effective in a late-stage study in reducing excess levels of a hormone associated with a serious condition often seen in patients with chronic kidney disease requiring dialysis, Amgen Inc said on Thursday. Article link: http://www.reuters.com/article/2014/07/17/amgenthyroididUSL2N0PS2V620140717 Source website: http://www.reuters.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 30 Study Finds Many Flu Patients Not Treated Appropriately July 17, 2014 Antiviral drugs aren't prescribed often enough for patients at high risk for flu complications, while too many of them receive unneeded antibiotics, a new study says. The findings show that doctors require more training about the proper use of antiviral and antibiotic drugs in treating flu patients, the researchers said. Unnecessary use of antibiotics contributes to the development of antibiotic resistance. Article link: http://consumer.healthday.com/infectious-disease-information-21/ antibiotics-news-30/many-flu-patients-incorrectly-medicated-study-finds-689808.html Source website: http://consumer.healthday.com/ FDA committee to discuss adverse effects of testosterone products July 17, 2014 The U.S. Food and Drug Administration has called an advisory committee meeting on Sept. 17, to discuss the adverse cardiovascular outcomes with the usage of testosterone replacement therapy. The FDA has called for a joint meeting of the bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee. Article link: http://www.reuters.com/article/2014/07/17/us-fdadrugsafetyidUSKBN0FM2G320140717 Source website: http://www.reuters.com/ Antipsychotics Linked to Lower Brain Volume in Schizophrenia Patients July 18, 2014 Antipsychotic drugs are associated with a slight decrease in both brain cells and connections between brain cells in schizophrenia patients, a new study indicates. However, this loss of what is called brain volume does not worsen schizophrenia symptoms or affect overall mental function, researchers reported in the study published online July 18 in the journal PLoS One. Article link: http://consumer.healthday.com/general-health-information-16/prescriptiondrugnews-551/antipsychotics-lower-brain-volume-in-schizophrenia-patients-studyshows689921.html Source website: http://consumer.healthday.com/ Pancreatic cancer treatment that almost never was lands key FDA win July 21, 2014 Aduro BioTech's immune system-boosting treatment for fighting deadly pancreatic cancer won "breakthrough therapy" designation from regulators, the small Berkeley company said Monday. Copyright© PerformRx, LLC 2013 All Rights Reserved 31 The breakthrough therapy tag can accelerate approval of badly needed drugs from years to 60 days by speeding the Food and Drug Administration review of drugs that are a "substantial improvement" over existing therapies. Article link: http://www.bizjournals.com/sanfrancisco/blog/biotech/2014/07/pancreaticcanceraduro-gvax-steve-jobs.html Source website: http://www.bizjournals.com/ 3D Hepatitis C Combo Effective in HIV Patients July 21, 2014 An investigational drug combination for hepatitis C virus (HCV) was highly effective in patients who also had HIV, a researcher reported. In a multicenter, phase II/III, open-label trial, the so-called 3D combination of investigational drugs with different viral targets cleared HCV in more than 93% of coinfected patients treated for 12 weeks, according to Mark Sulkowski, MD, of Johns Hopkins University. Article link: http://www.medpagetoday.com/MeetingCoverage/IAC/46868 Source website: http://www.medpagetoday.com/ Asthma Drug May Help Those With Chronic Hives July 21, 2014 A drug already used to treat moderate-to-severe allergic asthma appears to offer relief to people with chronic hives who haven't been helped by standard medications, new research suggests. The prescription drug -- omalizumab (Xolair) -- is already available to treat hives, following U.S. Food and Drug Administration approval earlier this year for that use. Article link: http://consumer.healthday.com/respiratory-and-allergy-information-2/miscallergynews-17/asthma-drug-appears-to-help-chronic-hives-689967.html Source website: http://consumer.healthday.com/ Anti-Amyloid Drug Has Mixed Results July 21, 2014 The amyloid plaque-busting drug crenezumab for Alzheimer's disease failed to meet its primary endpoints in a phase II trial, but -- as was the case with another similar drug -the drug did show promise in a subgroup with mild symptoms. Article link: http://www.medpagetoday.com/MeetingCoverage/AAIC/46866 Source website: http://www.medpagetoday.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 32 Probiotics might help lower blood pressure July 21, 2014 Regularly consuming probiotics, or the “good” bacteria found in yogurt, milk and cheese, may help control blood pressure, according to a new review of past studies. Researchers found that consuming the proper amount of probiotics over at least two months appeared to modestly lower blood pressure. Article link: http://www.reuters.com/article/2014/07/21/us-probiotics-bloodpressureidUSKBN0FQ20M20140721 Source website: http://www.reuters.com/ Antibiotic resistance could be 'next pandemic,' CDC says July 22, 2014 Antibiotic resistance that turns ordinary disease-causing bacteria into illnesses that can't be controlled could bring about the "next pandemic," Centers for Disease Control and Prevention Director Tom Frieden warned at a National Press Club event Tuesday. Article link: http://www.usatoday.com/story/news/nation/2014/07/22/antibioticresistancebacteria-drugs-cdc-lab-safety-mers-anthrax/13005415/ Source website: http://www.usatoday.com/ Trials of new drug to prevent Alzheimer's disease July 23, 2014 An experimental drug that takes a new approach to Alzheimer's by targeting the buildup of brain proteins is enrolling participants at a clinical trial at the Nathan Kline Institute in Orangeburg, NY Article link: http://www.lohud.com/story/news/health/2014/07/22/alzheimers-drugstudy/ 13029159/ Source website: http://www.lohud.com/ Inovio Pharma's drug to treat cervical lesions meets trial goal July 23, 2014 Inovio Pharmaceuticals said its drug to treat abnormal growth of pre-cancerous cells on the surface of the cervix met its main goal in a mid-stage trial. Article link: http://www.reuters.com/article/2014/07/23/us-inovio-pharmafdaidUSKBN0FS1JT20140723 Source website: http://www.reuters.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 33 Why a Trial for a Vertex Cystic Fibrosis Drug Combo Sent Mixed Signals. July 23, 2014 The recent results of two highly-anticipated human studies of an experimental cystic fibrosis drug developed by Vertex Pharmaceuticals showed that patients had a statistically significant improvement in lung function, but many doctors characterized the improvement only as “modest.” Article link: http://blogs.wsj.com/pharmalot/2014/07/23/why-a-trial-for-a-vertexcysticfibrosisdrug-combo-sent-mixed-signals/ Source website: http://blogs.wsj.com/ Acetaminophen No Better Than Placebo for Back Pain July 23, 2014 About two-thirds of adults have lower back pain at some point in their lives, and most are told to take acetaminophen, sold under brand names like Tylenol, Anacin and Panadol. Medical guidelines around the world recommend acetaminophen as a first-line treatment. Article link: http://well.blogs.nytimes.com/2014/07/23/acetaminophen-no-betterthanplacebofor-back-pain/?ref=health Source website: http://well.blogs.nytimes.com/ Monitoring, Dose Adjustment for Pradaxa? July 23, 2014 Blood level monitoring and dose adjustment for dabigatran (Pradaxa) could reduce major bleeding risk by as much as 20% compared with unadjusted use, according to company documents allegedly hidden from physicians and regulators. Article link: http://www.medpagetoday.com/Cardiology/Arrhythmias/46901 Source website: http://www.medpagetoday.com/ Sanofi Pasteur starts shipping 2014 flu vaccine July 23, 2014 The first batch of vaccines for the upcoming flu season is on its way to pharmacies, hospitals and doctors offices. Some 65 million doses Sanofi Pasteur’s Fluzone vaccines were approved for release earlier this week by the Food and Drug Administration. Article link: http://www.drugstorenews.com/article/sanofi-pasteur-starts-shipping-2014flu-vaccine Source website: http://www.drugstorenews.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 34 More US girls now getting cervical cancer vaccine July 24, 2014 More teen girls are getting a controversial cervical cancer vaccine but the increase isn't much of a bump, the government reported Thursday. Last year's rise follows a couple of years when the girls' HPV vaccination rate was flat and health officials worried that it wouldn't budge. For girls ages 13 to 17, the rate is now up to about 38 percent of girls, from 33 percent. Article link: http://hosted.ap.org/dynamic/stories/U/US_MED_HPV_VACCINATIONS? SITE= AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2014-07-24-13-56-04 Source website: http://hosted.ap.org/ Keryx drug improves phosphorus, iron in kidney patients –trial July 24, 2014 A pivotal trial of Keryx Biopharmaceuticals' experimental drug Zerenex showed that it improved levels of serum phosphorus and iron in patients on kidney dialysis, according to results published on Thursday. The trial involved 441 patients, according to the Journal of the American Society of Nephrology, which published the results. Article link: http://www.reuters.com/article/2014/07/24/keryx-idUSL2N0PZ2V320140724 Source website: http://www.reuters.com/ FDA reviewing what could be first biosimilar drug July 24, 2014 The Food and Drug Administration is reviewing research data on what could become the first U.S.-approved "biosimilar" drug, a cheaper, sort-of generic version of a biologic drug. Nearly five years after Congress passed a law enabling future approval of biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug. Article link: http://hosted.ap.org/dynamic/stories/U/ US_NOVARTIS_BIOSIMILAR_DRUG? SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT Source website: http://hosted.ap.org/ FDA approves Flonase allergy relief for sale over-the-counter in the United States July 24, 2014 No. 1 prescribed allergy treatment ingredient1 to be available OTC GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Allergy Relief (fluticasone propionate 50 Copyright© PerformRx, LLC 2013 All Rights Reserved 35 mcg spray), containing the No. 1 prescribed allergy treatment ingredient1, as an overthecounter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies Article link: http://www.gsk.com/media/press-releases/2014/fda-approves-flonaseallergyrelief-for-sale-over-the-counter-in.html Source website: http://www.gsk.com/ Drugs to increase 'good' cholesterol may not cut deaths July 28, 2014 Drugs that have been investigated to increase so-called “good” cholesterol may not prevent deaths, heart attacks or strokes as many hoped, according to a new analysis. Due to limitations in existing studies and ongoing experiments involving these and other drugs, researchers not involved with the analysis caution that it’s too early to give up on medications that increase high-density lipoprotein (HDL) cholesterol, however. Article link: http://www.reuters.com/article/2014/07/28/us-hdl-cholesterolmedicationidUSKBN0FX1R520140728? feedType=RSS&feedName=healthNews Source website: http://www.reuters.com/ House passes bill aimed at reducing prescription drug abuse July 29, 2014 The House on Tuesday passed legislation by voice vote to establish enforcement standards for prescription drug abuse. Specifically, the measure would amend the Controlled Substances Act to modify the definition of "imminent danger to the public health or safety" so that it applies to drugs that pose present or foreseeable health risks. Article link: http://thehill.com/blogs/floor-action/house/213692-house-passes-bill-aimedatreducing-prescription-drug-abuse Source website: http://thehill.com/ $1,000 SOVALDI NOW HEPATITIS TREATMENT OF CHOICE July 29, 2014 The price may be high but so is demand. A new $1,000-per-pill drug has become the treatment of choice for Americans with hepatitis C, a liver-wasting disease that affects more than 3 million. Even with insurers reluctant to pay, Sovaldi prescriptions have eclipsed those for all other hepatitis C pills combined in a matter of months, new data from IMS Health indicate. The promise of a real cure, with fewer nasty side effects, has prompted Copyright© PerformRx, LLC 2013 All Rights Reserved 36 thousands to get treated. Article link: http://hosted.ap.org/dynamic/stories/U/ US_HEPATITIS_DRUG? SITE=AP&SECTION=HOME&TEMPLATE =DEFAULT&CTIME=2014-07-29-03-06-19 Source website: http://hosted.ap.org/ Clinical Trials may be Compromised by Online Patient Chatter July 30, 2014 Are patients jeopardizing clinical trials by discussing them on social media? There is growing fear in the medical community and the pharmaceutical industry that an increasing number of people who participate in clinical trials may indeed compromise research by chatting about treatments, side effects and enrollment tips on Facebook, online forums and blogs, according to The Wall Street Journal. Article link: http://blogs.wsj.com/pharmalot/2014/07/30/clinical-trials-may-becompromisedby-online-patient-chatter/ Source website: http://blogs.wsj.com/ Naltrexone may be effective in diminishing impulse control disorders in Parkinson's disease patients July 30, 2014 Up to 20 percent of Parkinson's disease (PD) patients and their families may confront a common but largely unrecognized challenge: the occurrence of impulse control disorders (ICDs) such as compulsive gambling, sexual behavior, eating, or spending. Yet the presence of PD in these patients can severely limit or complicate treatment options. A team of investigators from the Perelman School of Medicine at the University of Pennsylvania and the Parkinson's Disease Research, Education and Clinical Center (PADRECC) at the Philadelphia Veterans Affairs Medical Center conducted a pilot study and found that the opioid antagonist naltrexone may be an effective treatment for diminishing ICD symptoms in PD patients. The results were published in the journal Neurology. Article link: http://www.sciencedaily.com/releases/2014/07/140730120145. htm? utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+ sciencedaily+%28Latest+Science+News+--+ScienceDaily%29 Source website: http://www.sciencedaily.com/ FDA Boosts Sarepta With Prognosis for its Rare Disease Drug. July 30, 2014 For the first time in months, Sarepta Therapeutics investors and parents of children with Duchenne muscular dystrophy received some good news. A top FDA official says the agency is exploring all “potential pathways” to approve new drugs to treat the rare childhood disease, which causes muscles in boys to stop working and eventually results Copyright© PerformRx, LLC 2013 All Rights Reserved 37 in death because they can no longer breathe. Article link: http://blogs.wsj.com/pharmalot/2014/07/30/fda-boosts-sarepta-withprognosisfor-its-rare-disease-drug/ Source website: http://blogs.wsj.com/ Sanofi, Regeneron Drug Cuts Cholesterol in 9 Studies July 30, 2014 Sanofi (SAN) and Regeneron Pharmaceuticals (REGN)’s cholesterol drug cut levels of the artery-clogging protein in nine trials, and reduced the rate of heart attack, stroke and death in one test, as the companies race with Amgen (AMGN) to get a new treatment to market. Article link: http://www.bloomberg.com/news/2014-07-30/sanofi-cholesterol-drugmeetsmain-goal-of-9-trials.html Source website: http://www.bloomberg.com/ Menopause HT Doesn't Touch Arterial Plaque July 30, 2014 Hormone replacement therapy early in menopause does not reduce the risk of atherosclerosis in low-risk women, a finding now confirmed by data from the KEEPS trial. During 4 years in the trial, women's carotid intima-media thickness (CIMT) rose similarly whether they got progesterone (Prometrium) with oral conjugated equine estrogen (Premarin) or with transdermal estradiol (Climara) or placebo, S. Mitchell Harman, MD, PhD, of the Phoenix VA Health Care System, and colleagues found. Article link: http://www.medpagetoday.com/Cardiology/Atherosclerosis/46998 Source website: http://www.medpagetoday.com/ The Pill linked to breast cancer risk for younger women August 1, 2014 A new statistical analysis finds that women under age 50 who were diagnosed with breast cancer were also more likely to have recently been on some versions of the Pill. The increased cancer risk still translates to less than a one percent chance of developing breast cancer for most younger women, researchers emphasize, so the results should not outweigh the many benefits of taking oral contraceptives. Source website: reuters.com Copyright© PerformRx, LLC 2013 All Rights Reserved 38 Statin guidelines change, but your doctor may not go along August 4, 2014 By Will Boggs MD New guidelines from the American College of Cardiology and American Heart Association would change the way doctors prescribe cholesterol-lowing statin drugs, but not every doctor agrees with the new strategy. Source website: reuters.com Amgen blood cancer drug succeeds in late-stage study August 4, 2014 Amgen said on Monday its Kyprolis combined with standard treatment helped patients with relapsed multiple myeloma live significantly longer before their blood cancer worsened, compared with the standard therapy, according to interim data from an eagerly-anticipated late stage study. Source website: reuters.com Ebola Drug Made From Tobacco Plant Saves U.S. Aid Workers August 4, 2014 A tiny San Diego-based company provided an experimental Ebola treatment for two Americans infected with the deadly virus in Liberia. The biotechnology drug, produced with tobacco plants, appears to be working. Source website: bloomberg.com Baby aspirin? Many doctors don't recommend, despite guidelines August 5, 2014 A majority of middle-aged men and women eligible to take aspirin to prevent heart attack and stroke do not recall their doctors ever telling them to do so, according to a University of Rochester study of a national sample of more than 3,000 patients. Source website: sciencedaily.com Hopes build for new Novartis heart failure drug August 5, 2014 Expectations are building for a new heart failure drug from Novartis viewed as a likely multibillion-dollar seller, with two surveys of cardiologists published on Tuesday highlighting its potential. A large clinical trial with LCZ696 was stopped early in March because the benefit to patients was overwhelmingly positive. Just how good the drug was will be disclosed at a medical meeting in Spain at the end of this month. Source website: reuters.com Copyright© PerformRx, LLC 2013 All Rights Reserved 39 FDA authorizes Ebola test; vaccine will probably take until 2015 August 6, 2014 The FDA has authorized use of an unapproved Ebola virus test under a special emergency use provision, although efforts to develop a vaccine for the deadly illness are unlikely to bear fruit until 2015, officials say. Source website: latimes.com Study: Pharmacist adherence interventions help lower overall health costs August 6, 2014 Community pharmacists can dramatically help their patients stick to their prescription regimens, according to a new study led by researchers at the University of Pittsburgh School of Pharmacy. The findings, reported Monday in Health Affairs, also suggest that greater adherence to medications can lead to a reduction in emergency room visits and hospital admissions, thereby lowering healthcare costs for a variety of chronic conditions, including diabetes and asthma. Source website: drugstorenews.com Daily Aspirin May Help Prevent Cancer, Study Shows August 6, 2014 Taking aspirin every day appears to reduce the odds of developing and dying from colon, stomach or esophageal cancer, a new study suggests. Based on a review of available studies, researchers determined that the benefits of aspirin therapy for preventing cancer outweigh the risks. Millions of people already take this inexpensive drug to prevent or treat heart disease. Source website: consumer.healthday.com Researchers concerned about safety of new drugs August 6, 2014 Study compared warning and withdrawal rates for drugs released before and after the drug industry increased funding to the FDA to expedite drug approvals What's safer: a newly approved drug or one that has been on the market much longer? Newer drugs have a one in three chance of acquiring a black box warning or being withdrawn for safety reasons within 25 years of their approval, according to a new study by researchers from Cambridge Health Alliance /Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen. The study, published today in the August issue of Health Affairs, is the largest on this topic, encompassing all of the drugs approved by the U.S. Food and Drug Administration (FDA) over a 35-year period. Source website: medicalnewstoday.com Copyright© PerformRx, LLC 2013 All Rights Reserved 40 Low Vitamin D Levels May Boost Alzheimer's Risk, Study Finds August 6, 2014 Older adults with too little vitamin D in their blood may have twice the risk of developing Alzheimer's disease as seniors with sufficient levels of the "sunshine vitamin," a new study finds. The research -- based on more than 1,600 adults over age 65 -- found the risk for Alzheimer's and other forms of dementia increased with the severity of vitamin D deficiency. Source website: consumer.healthday.com Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns August 11, 2014 RAC Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month. Source website: raps.org Short Latent TB Therapy Matches Standard Care August 11, 2014 Short courses of rifamycin-containing treatment regimens prevented active tuberculosis as well as standard monotherapy did, researchers reported. In a Bayesian network meta-analysis, some of the rifamycin-containing regimens also were less likely to cause liver damage than standard therapy with isoniazid (Nydrazid), according to Helen Stagg, PhD, of University College London, and colleagues. Source website: medpagetoday.com Guidelines: Treat Sickest HCV Patients First August 11, 2014 All patients with chronic hepatitis C (HCV) can benefit from new treatment regimens but some should get therapy more urgently than others, according to new guidelines. Patients with advanced fibrosis or who have had a liver transplant are at the "highest need for urgent treatment," according to Donald Jensen, MD, of the University of Chicago Medical Center, co-chair of an HCV guidelines panel organized by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases, in collaboration with the International Antiviral Society-USA (IAS-USA). Source website: medpagetoday.com Copyright© PerformRx, LLC 2013 All Rights Reserved 41 Study: Digoxin Risky for New Afib August 11, 2014 Digoxin was associated with increased risk of death in patients with newly diagnosed atrial fibrillation (Afib), independent of drug adherence, kidney function, cardiovascular comorbidities, and concomitant therapies, researchers reported. Source website: medpagetoday.com Bisphosphonates for osteoporosis not associated with reduced breast cancer risk, study suggests August 11, 2014 An analysis of data from two randomized clinical trials finds that three to four years of treatment with bisphosphonates to improve bone density is not linked to reduced risk of invasive postmenopausal breast cancer. Source website: sciencedaily.com Statins Don’t Require Routine Liver Tests August 11, 2014 When statins first came into wide use, warnings about possible liver damage were common, and some patients on the cholesterol-lowering drugs have their liver function monitored. Now a study has found that the risk was probably exaggerated. Source website: nytimes.com Many meds taken by seniors can raise risk of falls August 12, 2014 Half of the 20 most commonly prescribed medications taken by older adults may raise the risk of falls, according to new research. Painkillers and antidepressants were most strongly tied to a greater likelihood of being injured in a fall, the study of 64,000 Swedes over age 65 found. Severe injuries were significantly more common with 11 out of the 20 medications studied. Source website: reuters.com From Riches to Rags: Vertex Discontinues Incivek as Sales Evaporate. August 12, 2014 Talk about a reversal of fortunes. Three years after being heralded as the fastest drug launch ever and quickly racking up $1 billion in sales, the Incivek hepatitis C treatment will be discontinued this coming October by Vertex Pharmaceuticals . Source website: wsj.com Copyright© PerformRx, LLC 2013 All Rights Reserved 42 U.S. advisory panel recommends Prevnar 13 vaccine for elderly August 13, 2014 An influential U.S. medical advisory panel on Wednesday recommended that people 65 and older be given Pfizer Inc's blockbuster Prevnar 13 vaccine to protect against pneumococcal bacteria that can cause pneumonia and other infections. Source website: reuters.com Children Prescribed Growth Hormone May Face Stroke Risk Later: Study August 13, 2014 Children who are prescribed human growth hormone may be at greater risk of a stroke in early adulthood than their peers are, a new study suggests. While the study raises important questions about the safety of human growth hormone treatments, the study's French researchers encouraged parents to discuss the pros and cons of treatment with their child's physician. Source website: consumer.healthday.com Injecting bacteria shrinks tumors in dogs and one patient: study August 13, 2014 Common soil bacteria injected into solid cancers in pet dogs and one human patient shrank many of the tumors, scientists reported on Wednesday. The preliminary findings offered hope that the experimental treatment could turn out to be more effective than existing cancer therapies for some inoperable tumors such as those of the lung, breast, and pancreas, which often fail to respond to radiation and chemotherapy. Source website: reuters.com API Provides Open Access to FDA Recall Data As part of the Food and Drug Administration’s recently launched openFDA initiative, the regulatory agency is for the first time offering an application programming interface providing web developers and researchers direct access to millions of reports on drug adverse events and medication errors that have been submitted to the FDA since 2004. Article link: http://www.healthdatamanagement.com/news/ API-Provides-Open-AccesstoFDA-Recall-Data-48453-1.html Source website: http://www.healthdatamanagement.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 43 Contraception By Remote Control? Implantable Chip Nears Trials In the not-too-distant future, an implanted microchip could be the best form of birth control. Backed by the Bill & Miranda Gates Foundation Family Planning program, MicroCHIPS is starting pre-clinical testing of a new wireless device that delivers 30 micrograms of levonorgestrel — a synthetic hormone used in many contraceptives — every day for up to 16 years. That is far longer than any intrauterine device (IUD) on the market. (Copper IUDs can last for 10 years, while hormonal ones last for about five years). The chip even comes with a remote control, which lets women turn it off and on again with the press of a button. It’s not quite ready for the widespread human use yet; researchers are still working out how to encrypt the chips, important in preventing hackers from seriously upsetting someone’s life plans. If all goes according to plan, the company hopes the device will become available by 2018, and the technology could be adapted to deliver a number of other drugs as well. Article link: http://www.nbcnews.com/#/tech/innovation/contraception-remotecontrolimplantablechip-nears-trials-n149771 Source website: http://www.nbcnews.com/ Zohydro details timeframe for new Zohydro version The drugmaker Zogenix says a harder-to-abuse version of its powerful painkiller Zohydro could be reviewed by regulators this fall and, if approved, might hit the market early next year. The San Diego company said Wednesday that it recently met with Food and Drug Administration representatives, and it expects to submit an extended release, capsule version of Zohydro to the FDA by October. Article link: http://www.miamiherald.com/2014/07/02/4214589/zohydro-detailstimeframefor. html Source website: http://www.miamiherald.com/ German database study hints diabetes drug cuts Alzheimer's risk A large German study is the latest clinical trial to suggest that a cheap generic treatment for diabetes can stave off symptoms of Alzheimer's disease, although conclusive proof from a more formal trial could be about five years away. Article link: http://www.reuters.com/article/2014/07/14/us-alzheimers-preventionactosidUSKBN0FJ0VJ20140714 Source website: http://www.reuters.com/ Copyright© PerformRx, LLC 2013 All Rights Reserved 44 RECALLS* Product Type Drugs Product Description Code info. Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. UPC: 7 99475 35350 5. Lot #: L1P1-6100 (expiry 6/25/2016) and L1P2-6000 (expiry 9/16/2016). Class I Drugs Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle Lot #13165; Exp. 05/17 Class I Drugs Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only NDC 25682-001-01 UPC 3 25682-001-01 6. Class I Drugs Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. NDC 62037-0696-90 Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, NDC 00527-1426-36 Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15 Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90 Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36 Class I Drugs Copyright© PerformRx, LLC 2013 All Rights Reserved Class Class I Reason for Recall Recalling firm Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug. Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. Sung Soo Kim Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL Bacai Inc. Dba Ky Duyen House Alexion Pharmaceutical s, Inc. Shamrock Medical Solutions Group LLC Shamrock Medical Solutions Group LLC 45 Product Type Drugs Drugs Drugs Drugs Drugs Product Description Code info. metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, NDC 53746-178-01 Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, NDC 0093-0293-10 Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01 Reason for Recall Recalling firm Class I Labeling: Label Mix up; product labeled did not indicated Extended Release Shamrock Medical Solutions Group LLC lot 29C220, Exp. 11/15 Class II Teva Pharmaceutical s USA Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11 Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Vial - 4212AAP1, Kit - 309316, Exp. 07/15 Class II Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets. Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample All lot numbers and exp dates Class II Medical Supply Liquidators Llc Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Copyright© PerformRx, LLC 2013 All Rights Reserved Class Janssen Pharmaceutical s, Inc. Medical Supply Liquidators Llc 46 Product Type Drugs Product Description Code info. BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Drugs Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Drugs Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial All lot numbers and exp dates Class II Drugs Vitamin B12 All lot numbers Methylcobalamin 5000 and exp dates Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial Class II Drugs MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Class II All lot numbers and exp dates Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable Medical Supply Liquidators Llc Medical Supply Liquidators Llc Medical Supply Liquidators Llc Medical Supply Liquidators Llc Medical Supply Liquidators Llc 47 Product Type Product Description Code info. Class Drugs Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. All lot numbers and exp dates Class II Drugs Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Drugs B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. All lot numbers and exp dates Class II Drugs Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Vial Copyright© PerformRx, LLC 2013 All Rights Reserved Reason for Recall products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with Recalling firm Medical Supply Liquidators Llc Medical Supply Liquidators Llc Medical Supply Liquidators Llc Medical Supply Liquidators Llc 48 Product Type Product Description Code info. Drugs Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile All lot numbers and exp dates Class II Drugs G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Drugs L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Drugs Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial All lot numbers and exp dates Class II Drugs Cephalexin Capsules, Lot #: a) USP, 250 mg, packaged in AGL0098B, Copyright© PerformRx, LLC 2013 All Rights Reserved Class Class II Reason for Recall the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer CGMP Deviations: These products are Recalling firm Medical Supply Liquidators Llc Medical Supply Liquidators Llc Medical Supply Liquidators Llc Medical Supply Liquidators Llc Caraco Pharmaceutical 49 Product Type Drugs Product Description Code info. AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, ... More Cephalexin Capsules, Lot #: a) USP, 500 mg, packaged in AGL0058B, a) 100-count bottles AGL0059B, (NDC 62756-294-88) and AGL0060B, b) 500-count bottles AGL0061B, Exp (NDC 62756-294-13), Rx 06/14; Class a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only Copyright© PerformRx, LLC 2013 All Rights Reserved Class II Reason for Recall Recalling firm being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. Laboratories, Ltd. CGMP Deviations: These products are being recalled because they were manufactured with active Caraco Pharmaceutical Laboratories, Ltd. 50 Product Type Product Description Code info. only Drugs Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), NDC 126600048 CAS #522-48-5 Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, NDC 63739-644-10 AGL0062B, AGL0063B, AGL0064B, Exp 07/14; AGL0083B, AGL0084B, AGL0085B, AGL0086B, AGL0087B, AGL0088B, AGL0089B, AGL0090B, Exp 08/14; AGL0120B, AGL0121B, AGL0122B, AGL0123B, Exp 11/14; AGM0001B, AGM0002B, AGM0003B, AGM0004B, Exp 12/14; AGM0021B, AGM0022B, AGM0023B, AGM0024B, Exp 01/15; AGM0031B, AGM0032B, AGM0033B, AGM0034B, Exp 02/15; AGM0053B, AGM0054B, ... More Lot: 168.862, Expiry: 6/2017 Drugs Lot 102492, exp 01/2016 Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. Class II Class II CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Presence of Foreign Substance; tablets may contain stainless steel metal SST Corporation Mckesson Packaging Services 51 Product Type Product Description Drugs Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. NDC: 19392120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing. Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026 Lot #: MB140417; Expiry: 04/2017. Class II all lot codes Class II Drugs Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. all lot codes, .25 oz and 2 oz sizes Class II Drugs Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008. Dermamedics Complexion Repair Topical Rehydrating all lot codes Class II all lot codes Class II Drugs Drugs Code info. Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm particulates Microbial Contamination of Non-Sterile Product HLI dba Humphreyline Inc Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Marketed without an Approved NDA/ANDA: FDA has Dermamedics, L.L.C. Dermamedics, L.L.C. Dermamedics, L.L.C. Dermamedics, L.L.C. 52 Product Type Drugs Product Description Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002. Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068. Code info. Class Reason for Recall Recalling firm determined that the products are unapproved new drugs and misbranded. all lot codes Class II Drugs Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019 all lot codes Class II Drugs Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005 all lot codes Class II Drugs Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, all lot codes 30 ml and 50 ml Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. Dermamedics, L.L.C. Dermamedics, L.L.C. Dermamedics, L.L.C. 53 Product Type Drugs Drugs Product Description respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007. Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively. triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, NDC# 0093-8055-78 Code info. Class Reason for Recall Recalling firm all lot codes 30 ml and 50 ml Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C. 35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; Class II Failed Impurities/Degradati on Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole. Teva Pharmaceutical s USA Copyright© PerformRx, LLC 2013 All Rights Reserved 54 Product Type Product Description Drugs Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, NDC # 59746339-90 Drugs Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, NDC 65597-113-30 Drugs Reason for Recall Recalling firm Class II Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. Jubilant Cadista Pharmaceutical s Inc. Lot #213655B Exp 12/31/2014 Class II Daiichi Sankyo Pharma Development Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only, NDC 65597-10330 and NDC 65597-10390 30 count - Lot #0002055 Exp 11/30/2016; 90 count - Lot #0002063 Exp 12/31/2016 Class II Drugs Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, NDC 65597-105-30 Lot #0002106 Exp 11/30/2016 Class II Drugs Tribenzor Tablets (olmesartan medoxomil/amlodipine/h ydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only NDC 65597-116-30 Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, NDC 65597-701-18 Lot #211836 Exp - 11/30/2016 Class II Lot NVWG Exp 11/30/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Drugs Code info. 35430184A, Exp. 04/15. Lot #14P0292, Exp 04/2016 Copyright© PerformRx, LLC 2013 All Rights Reserved Class Daiichi Sankyo Pharma Development Daiichi Sankyo Pharma Development Daiichi Sankyo Pharma Development Daiichi Sankyo Pharma Development 55 Product Type Drugs Product Description Code info. Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only, NDC 65597-10430 and 65597-104-90 30 count - Lot #0002096 Exp 12/31/2016; 90 count - Lot #0002058 Exp 12/31/2016 Drugs Benicar HCT Tablets Lot #0002073 (olmesartan Exp medoxomil/hydrochlorot 12/31/2016 hiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, NDC 65597-106-30 Class II Drugs Benicar HCT Tablets (olmesartan medoxomil/hydrochlorot hiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, NDC 65597-107-30 and NDC 65597-107-90 Fagron, Phytobase Cream, 500 g, RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oilsolvents ingredients. Contains Phytosomes (Plant Oil Bodies), NDC 51552-1205-6. Fagron, Pentravan Base 2.5 Kg, RX only, For prescription compouning, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrancefree, NDC 51552-0919-8. Fagron, Pentravan Plus Base 2.5 Kg, RX only, For prescription compounding, Oil-inwater emulsion base alternative to PLO gel, 30 count/Lot #0002073 Exp 12/31/2016; 90 count/Lot #0002078 Exp 12/31/2016 Class II Lot # 13J30U17-015413; Exp 10/15 Lot # 13J30-U16015425; Exp 10/15 Lot # 13I06-U05014199; Exp 10/15 Class II Lot # 14C24U04-018189; Exp. 03/17 Lot # 14C26-U02018214; Exp. 03/17 Class II Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. Fagron, Inc Lot # 14C03U09-017846; Exp. 03/17 Lot # 14B28-U06017824; Exp. 03/17 Class II Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. Fagron, Inc Drugs Drugs Drugs Copyright© PerformRx, LLC 2013 All Rights Reserved Class Class II Reason for Recall Recalling firm Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. Daiichi Sankyo Pharma Development Daiichi Sankyo Pharma Development Daiichi Sankyo Pharma Development Fagron, Inc 56 Product Type Drugs Drugs Drugs Drugs Drugs Product Description Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Preserved and fragrance-free, NDC 51552-1285-8, Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10 Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, NDC 16714-586-01 Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, NDC 53746-272-01 Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, NDC 00904-577960 Levofloxacin 750 mg/250 mL D5W, Trinity Care Code info. Class Reason for Recall Recalling firm Presence of Foreign Substance; tablets may contain stainless steel metal particulates Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets Sandoz Incorporated Lot EJ9591 Class II Use by 12/14/2012, Lot# 002B90, NDC 16714-58601 Class II Lot 00288N, Use By: 9/15/2012, NDC 53746-27201 Class II Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg Shamrock Medical Solutions Group LLC Lot #: 002H79, Use By: 06/19/2013, NDC: 009045779-60 Class II Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg Shamrock Medical Solutions Group LLC Rx 29184 Exp 5/28/14 Class II Lack of Assurance of Sterility; All lots of Franck's Lab Inc dba Trinity Copyright© PerformRx, LLC 2013 All Rights Reserved Shamrock Medical Solutions Group LLC 57 Product Type Product Description Code info. Class Drugs Vancomycin 750 mg/100 mL 0.9%NS, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14 Rx # 28289, Exp 02/5/14; Rx # 29189, Exp 05/23/14 Class II Drugs Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14 Rx 29183 Exp, 5/21/2014 Class II Drugs Desferal 2.5 gm/14 mL Sterile Water, Rx # 28314, Discard After 05/22/14 Rx 28314 Exp 5/22/2014 Class II Solutions, 202-C SW 17th Street, Ocala, FL 344715138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14 Copyright© PerformRx, LLC 2013 All Rights Reserved Reason for Recall Recalling firm sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions 58 Product Type Product Description Code info. Drugs Cefepime 2 gm/100 mL D5W, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14 Rx # 28288, Exp 02/4/14; Rx # 29176, Exp 05/21/14; Rx # 28829, Exp 05/17/14 Class II Drugs Ceftriaxone 2 gm/100 mL 0.9%NS, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14 Rx # 29039, Exp 05/05/14 & 05/20/14; Rx # 29204, Exp 05/23/14; Rx # 29161, Exp 05/19/14 Class II Drugs Cubicin 486 mg/100 mL 0.9%NS, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014 Rx # 29038, Exp 05/20/14 Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Recalling firm Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions 59 Product Type Drugs Product Description Code info. Invanz (ertapenem)1 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14 Rx # 29157, Exp 5/19/14; Rx # 29097, Exp 5/20/14 Class II Drugs Meropenem 1 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14 Rx # 29087 Exp. 5/28/2014 Class II Drugs Nafcillin 12 gm/300 mL, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14 Rx 29162 Exp. 5/21/2014 Class II Drugs Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14 Rx # 29082 Exp. 5/19/14 Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions 60 Product Type Product Description Code info. Drugs Desferal 2 gm/8 mL Sterile Water, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14 Rx # 27767, Exp 05/23/14 Class II Drugs Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, For Parenteral Use Only, Rx #28694, Discard After 05/22/14 Rx #28694, Exp 05/22/14 Class II Drugs Cefazolin 1 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14 Rx # 28837, Exp 04/11/14 Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA Recalling firm Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions 61 Product Type Product Description Code info. Drugs Cubicin 444 mg/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14 Rx # 29114, Exp 05/13/14 Class II Drugs Normal Saline 10 mL/10 mL Syringe, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15 Rx # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15 Class II Drugs Ambisome 285 mg/250 mL D5W, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14 Rx # 28300, Exp 02/7/14 Class II Drugs ANA Kit, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15 Rx # 28838, Exp 03/4/15 Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the Recalling firm Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions 62 Product Type Product Description Code info. Drugs Tobramycin 300 mg/7.5 mL Syringe (for Neb), For Parenteral Use Only, Rx # 28503, Discard After 02/27/14 Rx # 28503, Exp 02/27/14 Class II Drugs Vancomycin 1 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14 Rx # 29186, Exp 05/22/14; Rx # 29010, Exp 05/22/14 Class II Drugs Vancomycin 1.25 gm/250 mL 0.9%NS, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14 Rx # 29140, Exp 05/23/14 Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control Recalling firm Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions 63 Product Type Product Description Code info. Drugs Vancomycin 750 mg/150mL D5W, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14 Rx # 28878, Exp 05/16/14 Class II Drugs Vancomycin 1.25 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14 Rx # 29185, Exp 05/23/14 Class II Drugs Cubicin 543 mg/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14 Rx # 29175, Exp 05/21/14; Rx # 28830, Exp 05/17/14 Class II Drugs Cubicin 600 mg/100 mL 0.9%NS, For Parenteral Rx # 29096, Exp 05/20/14 Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of Recalling firm Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity 64 Product Type Product Description Code info. Class Drugs Cubicin 700 mg/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14 Rx # 29083, Exp 05/21/14 Class II Drugs Cefepime 1 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14 Rx # 29011, Exp 05/21/14; Rx # 29141, Exp 05/22/14; Rx # 29171, Exp 05/20/14 Class II Drugs Ceftriaxone 2 gm/100 mL D5W, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14 Rx # 29150, Exp 05/17/14 Class II Use Only, Rx # 29096, Discard After 05/20/14 Copyright© PerformRx, LLC 2013 All Rights Reserved Reason for Recall Recalling firm sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions 65 Product Type Product Description Code info. Drugs Cefepime 2 gm/100 mL 0.9%NS, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14 Rx # 28879, Exp 05/21/14 Class II Drugs Ceftriaxone 1 gm/50 mL D5W, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14 Rx # 29190, Exp 05/23/14; Rx # 29068, Exp 05/18/14 Class II Drugs Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I13145 September 2015 J13165 October 2015 J13166 October 2015 Class II Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number Recalling firm Franck's Lab Inc dba Trinity Care Solutions Franck's Lab Inc dba Trinity Care Solutions Axcentria Pharmaceutical s, LLC 66 Product Type Drugs Drugs Drugs Product Description Code info. ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. NDC: 054365-400-13. Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Singledose Fliptop Vial, Rx only. NDC: 0409-9094-61. Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only Lot #: 71132, Expiry: 02/2017 Class II Lack of Assurance of CareFusion Sterility; Immediate 213, LLC product pouches may not be properly sealed. Lot #: 39474DK, Expiry: 03/01/2016. Class II Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. Hospira Inc. Lot #s: TD-100: PCBA Lot 60 TD100: PCBA Lot 61 TD-100: PCBA Lot 62 TD100: PCBA Lot 63 Optineb: PCBA Lot 72 Optineb: PCBA Lot 73 SERIAL NUMBERS: Kit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's 23103954 23103976 23104015 23104017 23104006 23104000 23103995 23104018 23104016 Optineb devices shipped to Caremark: Kit S/N ML 3660 MP 3662 ML 3665 MP 3667 MP 3668 MP 3676 MP 3683 Class II Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use. United Therapeutics Corp. Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm 67 Product Type Product Description Code info. Class Reason for Recall Recalling firm MP 3690 ML 3691 MP 3692 Optineb S/N's 20900207 20900212 20900219 20900222 20900226 20900209 20900213 20900225 20900227 20900241 20900310 20900295 20900293 20900291 20900240 20900308 20900294 20900292 20900290 Kit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's 20900262 20900283 20900285 20900265 20900253 20900264 20900284 20900286 20900268 20900315 NPR Device Not Part of Recall MP=Mount Prospect; MLMonroeville TD100 devices shipped to Accredo: Kit S/N Copyright© PerformRx, LLC 2013 All Rights Reserved 68 Product Type Product Description Drugs Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, NDC 63323-403-02 Code info. 1879 1880 1881 1882 1883 1884 1885 1886 1887 TD-100 S/N's 23103982 23103985 23103988 23103990 23103992 23103984 23103986 23103989 23103991 23103993 23103959 23103961 23103963 23103994 23103958 23103960 23103962 23103972 Kit S/N 1888 1889 1890 1891 1892 1893 1899 1900 1901 TD-100 ... Lot # 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14 6004200; 07/14 6004509; 08/14 6004510; 08/14 6004661; 09/14 6005157; 11/14 6005158; 11/14 6005197; 11/14 6005198; 11/14 6005446; 01/15 6005447; 01/15 6005702; 03/15 6005703; Copyright© PerformRx, LLC 2013 All Rights Reserved Class Class II Reason for Recall Recalling firm Presence of Fresenius Kabi Particular Matter: USA, LLC Potential glass delamination and consistent with glass particulates observed in sample vials. 69 Product Type Product Description Drugs Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, NDC 63323-403-10 Drugs Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, Code info. 03/15 6005790; 03/15 6005791; 03/15 6006005; 05/15 6006006; 05/15 6006091; 05/15 6006211; 06/15 6006212; 06/15 6006396; 07/15 6006397; 07/15 Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15 Lot 36225DD, exp 12/01/2015 Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm Class II Presence of Fresenius Kabi Particular Matter: USA, LLC Potential glass delamination and consistent with glass particulates observed in sample vials. Class II Presence of Particulate Matter; metal embedded in the glass vial and Hospira Inc. 70 Product Type Product Description Code info. Class packaged 50/20 mL glass vials/carton, NDC 04092267-20 BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, NDC 75901-7210-53. Lot #: 6156-0, Exp 03/07/14 Class II Drugs Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, NDC 0054-3120-41. Lot # 360122A, EXP Date: MAY 2015 Class II Drugs Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, NDC 0093-744256 Lot #: F47008, Exp. 7/2015 Class II Drugs Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, NDC 0409-7793-62 Lot # 34-811-KL, 36-106-KL, 36114-KL; Exp. 12/15; 36-101KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38305-KL, Exp. Class II Drugs Copyright© PerformRx, LLC 2013 All Rights Reserved Reason for Recall visible particles floating in the solution Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial. Failed Impurity/Degradatio n Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage. Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag. Recalling firm Healix Infusion Therapy, Inc. Boehringer Ingelheim Roxane Inc Teva Pharmaceutical s USA Hospira Inc. 71 Product Type Product Description Drugs Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-126101, b) 1000-count bottles, NDC 0143-126110, c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000count bottles, NDC 61748-013-10 Drugs Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. NDC 0456-1420-07. Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only , Product Code 2J1415, NDC 10019-055-61. Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only Drugs Drugs Drugs Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only Code info. Reason for Recall Recalling firm Class II Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point. West-Ward Pharmaceutical Corp. Class II Failed Dissolution Specifications: Drug failed stage III dissolution testing. Forest Pharmaceutical s Inc Lot #: C926923, Exp 01/16 Class II Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. Baxter Healthcare Corp. Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14; 04212014@4 / BUD 05/21/2014 Lot # / Beyond Use Date: 05012014@36 / 05/15/14 Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an Brookfield Prescription Center Inc. dba MD Custom Rx 2/16 Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14 Lot # A308879, Expiry: 09/2015 Copyright© PerformRx, LLC 2013 All Rights Reserved Class 72 Product Type Product Description Drugs HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only Drugs HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only Drugs HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only Drugs HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units Code info. Lot # / Beyond Use Date: 05192014@15 / BUD 07/18/14; 04142014@39 / BUD 6-13-14; 04182014@4 / BUD 6-17-14; 04162014@12 / BUD 06/15/14; 05092014@34 / BUD 07/08/14; 04162014@35 / BUD 06/15/14; 05232014@33 / BUD 07/22/14; 05022014@36 / BUD 7/1/14; ... More Lot # / Beyond Use Date: 05022014@5 / BUD 07/01/14; 04032014@7 ... More Lot # / Beyond Use Date: 04232014@49 / BUD 06-22-14; 04232014@2 / BUD 06/22/14; 04252014@27 / BUD 06/24/14; 04162014@33 / BUD06/15/14; 05132014@2 / BUD 07/12/14; 05092014@39 BUD 7-8-14 Lot # / Beyond Use Date: 04302014@21 / BUD 06/29/14 Copyright© PerformRx, LLC 2013 All Rights Reserved Class Class II Reason for Recall Recalling firm incorrect solvent. Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. Brookfield Prescription Center Inc. dba MD Custom Rx Class II Incorrect/Undeclared Excipients: Specific drug products were compounded with an Brookfield Prescription Center Inc. dba MD Custom Rx 73 Product Type Drugs Product Description + 1000 mcg/mL drop, 8 mL bottle, Rx only Venlafaxine Hydrochloride ExtendedRelease Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. 30-Count Bottle NDC: 41616-758-83, 90Count Bottle: NDC 41616-758-81. Code info. Class Reason for Recall Recalling firm incorrect solvent. 30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015. Class II Drugs Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, NDC 0008-121130 Drugs Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, NDC 47335-154-40 Drugs Dextroamphetamine Lot # Sulfate Tablets, USP, 10 34013122A, Exp mg, 100-count bottles, Rx 11/15 only, NDC 0555-0953-02. Class II Drugs Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, Class II H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16 JKM7188A Lot #: a) 179271, Exp 08/14; b) and c) Copyright© PerformRx, LLC 2013 All Rights Reserved Class II Class II Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq. Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance. Failed Impurities/Degradati on Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. Crystallization: Crystal precipitate formation and an Caraco Pharmaceutical Laboratories, Ltd. Pfizer Us Pharmaceutical Group Caraco Pharmaceutical Laboratories, Ltd. Teva Pharmaceutical s USA Bausch & Lomb, Inc. 74 Product Type Product Description Code info. 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-38555, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-563 146791, 146932, ... More Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, NDC 0904-5315-38, UPC 3 09045 31538 5. Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15 Class II Drugs Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45count bottles, UPC 6 93749 74002 5 All lot codes Class II Drugs Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, UPC 6 93749 73502 1 All lot codes Class II Drugs Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm increase in the number of complaints associated with a gritty, sand-like feeling in the eye. Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and Bausch & Lomb, Inc. Thorne Research Inc Thorne Research Inc 75 Product Type Product Description Drugs TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1count bottle, Rx Only, NDC 57844-713-46 Drugs Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. NDC 0591-3561-15. Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL Drugs Drugs Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust Code info. Class Reason for Recall Recalling firm Class II labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. Chemical Contamination: TEVTROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process. Class II Subpotent Drug. Actavis Inc Lot 563.61, use by 05/31/14; Lot 2616, Use by 3/31/15 Class II John W Hollis Inc Lot# 938, Use by 08/17/14, Lot #1370; Use by Lot# 1818; Use by 11/08/14, 1/30/15; Lot# 2664, Use by Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. Lot # H11599A; Exp. 03/16 Lot # H11599B; Exp. 03/16 Lot # H12913A; Exp. 05/16 Lot # H12913B; Exp. 05/16 Lot # H12914A; Exp. 05/16 Lot # H12914B; Exp. 05/16 Lot # H13846A; Exp. 07/16 Lot # H13846B; Exp. 07/16 Lot #: 3100135, Expiry: 05/2014 Copyright© PerformRx, LLC 2013 All Rights Reserved Ferring Pharmaceutical s Inc John W Hollis Inc 76 Product Type Drugs Drugs Drugs Drugs Drugs Product Description Code info. pH, 10 mL CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL 4/18/15 Lot # 940, Best used by 08/01/14; Lot # 1090, Best used by 08/29/14; Lot # 1533, Best used by 05/24/14; Lot # 1838, Best used by 07/15/14; Lot# 2755, Best used by 10/06/14 Polidocanol 5% Solution Lot 1076, use by for Injection, each mL 08/28/14; Lot contains Polidocanol 2410, use by (Laureth 9) 50 mg, also 09/13/14; Lot contains Sterile Water for 2746, use by Injection, Ethyl Alcohol, 10/06/14 Anhydrous Chlorobutanol, 50 mL Vial Testosterone Cypionate lot# 1157, Use for Injection, each mL by 09/16/14; contains Testosterone lot# 2357, use Cypionate 200 mg, also by 06/01/14 contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL MIC PLUS B12, Lot 1507, Use by Adenosine, L-Carnitine, 5/18/14; Lot Contains: Methionine 1863, Use by 15mg, Choline 100mg, 7/20/14 Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE Mannitol 5% Solution for Lot 1507, Use by injection, Mannitol 50 5/18/14; Lot Copyright© PerformRx, LLC 2013 All Rights Reserved Class Reason for Recall Recalling firm Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II Lack of Assurance of Sterility: Lack of John W Hollis Inc 77 Product Type Drugs Drugs Drugs Drugs Product Description Code info. mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL 1863, Use by 7/20/14 B-Complex/Adenosine Inj sol, Adenosine-5Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Class Reason for Recall Recalling firm sterility assurance in compounded aseptically filled injectable products. Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Lot: 1731, Use by 7/01/14; Lot: 2190, Use by 8/24/14 Class II Lot # 1862, used by 7/20/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc a) 5 mL: Lot: 2319, best used by 6/04/14; Lot: 2510, best used by 6/22/14; Lot: 2576, best used by 6/25/14; Lot: 2624, best by 6/30/14; Lot: 2744, best used by 7/08/14; Lot: 3048, best used by 7/30/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; ... More Lot # 2095, Use by 8/17/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Copyright© PerformRx, LLC 2013 All Rights Reserved 78 Product Type Drugs Product Description Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL Drugs Papaverine HCl 30 mg, Phentolamine Mesylate Code info. Class Reason for Recall Recalling firm a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14 a) 5 mL: Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14; Lot: 2672, best used by 7/03/14; Lot: 3022, best used by 7/28/14; b) 10 mL: Lot: 2166, best used by 5/26/14; Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14 Lot: 2187, best used by 05/26/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II John W Hollis Inc a) 5 mL: Lot: 2488, best used Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. Lack of Assurance of Sterility: Lack of Copyright© PerformRx, LLC 2013 All Rights Reserved John W Hollis Inc 79 Product Type Product Description Code info. 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL Drugs LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, by 6/19/14; b) 10 mL: Lot: 2264, best used by 06/03/14; Lot: 2295, best used by 06/04/14 a) 5 mL: Lot: 2670 best used by 7/02/14; Lot 2855, best used by 7/15/14; b) 10 mL: Lot: 2303, best used by 6/04/14; Lot: 2343, best used by 6/08/14; Lot: 2600, best used by 6/29/14; lot: 2571, use by 9/23/14 Drugs Drugs Class Reason for Recall Recalling firm sterility assurance in compounded aseptically filled injectable products. Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Lot: 2789, Best used by: 7/10/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Lot 2868, Best used by 3/15/15 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc Copyright© PerformRx, LLC 2013 All Rights Reserved 80 Product Type Drugs Drugs Drugs Product Description Anhydrous Chlorobutanol, 50 mL Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, NDC 0085-1401-01 ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, NDC 55566-6500-3 Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, NDC 0555-9043-58 Code info. Class Reason for Recall Recalling firm Lot F0067 exp. 06/14, F0079 exp. 04/15 Class III Novartis Pharmaceutical s Corp. Lot Number:Expiry Date 0804.182B1:07/14; 0804.183B1:07/14; 0804.185A1:08/14; 0804.186B1:08/14; 0804.187B1:08/14; 0804.210A1:12/14; 0804.212A1:12/14; 0804.213A1:12/14; 0804.214A1:12/14; 0804.216B1:12/14; 0804.223B1:02/15 0804.225B1:03/15 Lot 3805324A Exp. 11/14 Class III Failed Content Uniformity Specification; out of specification results for particle size distribution Discoloration; due to prolonged heat exposure. Copyright© PerformRx, LLC 2013 All Rights Reserved Class III Ferring Pharmaceutical s Inc Failed Teva Impurities/Degradati Pharmaceutical on Specifications: s USA Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Aprif tablets due to out of specification impurity test results. 81 Product Type Drugs Product Description Code info. Class Reason for Recall Recalling firm Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, NDC 51285-114-58 Lot 33805507A, Exp. date 11/14 Class III Teva Pharmaceutical s USA Drugs Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, NDC 0555-9050-58 Lot 33805325A, Exp.11/14 Class III Drugs Velivet (desogestrel and ethinyl estradiol tablets triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, NDC 0555-9051-67 Lot 33805449A, Exp. 12/14 Class III Drugs VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only,NDC 63010-027-70 Lot H45241, exp. 11/16 Class III Drugs POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Lot #: 04413, Expiry: 02/15 Class III Failed Impurities/Degradati on Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Mircette tablets due to out of specification impurity test results. Failed Impurities/Degradati on Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Kariva tablets due to out of specification impurity test results. Failed Impurities/Degradati on Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Velivet distributed by Barr Laboratories, Inc. due to out of specification impurity test results. Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016. Does Not Meet Monograph: Phenylephrine and pseudoephedrine are Copyright© PerformRx, LLC 2013 All Rights Reserved Teva Pharmaceutical s USA Teva Pharmaceutical s USA Pfizer Inc. Poly Pharmaceutical s, Inc 82 Product Type Drugs Product Description Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only, NDC: 50991-713-16. LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. NDC: 50991-515-16. Code info. Class Reason for Recall Recalling firm below monograph specifications, and label inaccurately contains wording "Rx Only". Lot #: 03613, Expiry: 02/15 Class III Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015. Lot: 849R, Exp 04/2015 Class III Drugs Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, NDC 0168-0337-60. Drugs Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, NDC 0168-0336-60. Drugs Diltiazem HCl Extendedrelease Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, NDC 51079-947-08. Lot #: 3045659, 3048256, Exp 07/14 Class III Drugs DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium All lot codes and shipment dates are being recalled. Class III Copyright© PerformRx, LLC 2013 All Rights Reserved Class III Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Poly Pharmaceutical s, Inc Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Failed Impurities/Degradati on Specifications: High out-ofspecification results for a related compound obtained during routine stability testing. Stability Data Does Not Support Expiry Fougera Pharmaceutical s Inc. Fougera Pharmaceutical s Inc. Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Estee Lauder Inc 83 Product Type Product Description Code info. monofluorophosphate 0.76%, 2.6 oz/75 mL tube Drugs Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, NDC 39822-2000-1. 2.6oz/75ml. in a light green carton, UPC: 882381-07901-7 Code: D079-011000 Lot: PLNB1412, Exp 12/15 Drugs Orphenadrine Citrate Extended Release Tablets, 100 mg a)100count bottle, (NDC 01850022-01) b) 1000-count bottle, (NDC 0185-002210), Rx only. Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30count bottle), Rx only, NDC 0049-2710-30 Drugs Class Reason for Recall Recalling firm Class III Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride". Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. X-Gen Pharmaceutical s Inc. Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16 Class III Lot # V130822; Exp 01/15 Class III Drugs Aspirin DR Enteric Coated Lot 0093943 Tablets, USP 325 mg, UD 750 tablets (25x30) Class III Drugs OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. NDC: 0054-0523-41. buPROPion HCl Extended-Release Tablets, USP (SR), 100 Lot #: 360241A, Expiry: 05/2015. Class III Lot #: DN10635, Exp 01/15; DM13402, Class III Drugs Copyright© PerformRx, LLC 2013 All Rights Reserved Failed Impurities/Degradati on Specifications: Product from this lot may not meet specifications for a product degradant. Failed Dissolution Specification; at the 12 month time interval. Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Failed Impurities/Degradati on Products: Out of Sandoz Inc Pfizer Inc. Mckesson Packaging Services Boehringer Ingelheim Roxane Inc Wockhardt Usa Inc. 84 Product Type Product Description Code info. mg, 500-count bottle, Rx Only, NDC 64679-101-07. Drugs Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only; NDC 0078-0436-05, UPC 3 0078-0436-05 2. DN10247, Exp 11/14; and DM13449, Exp 07/14 Lot # PKTS, Exp 01/17 Drugs E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, NDC 32909-764-01. Drugs Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, NDC 00093073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, NDC 00093073-23 Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15 Lot H43272, H43265 Exp. 09/14 Class Class III Class III Class III Reason for Recall specification levels of the impurity mchlorobenzoic acid were observed. Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers. Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months. Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0 Recalling firm Novartis Pharmaceutical s Corp. Bracco Diagnostic Inc Pfizer Inc. *Please refer to FDA website for further information http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm Copyright© PerformRx, LLC 2013 All Rights Reserved 85 CURRENT DRUG SHORTAGES Doxazosin Tablets May 01, 2014 Reason for the Shortage • Teva discontinued all unit-dose presentations in November, 2012. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=586 Source link: http://www.ashp.org Dactinomycin Injection May 07, 2014 Reason for the Shortage • • • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure, but dactinomycin is not one of these products. Recordati acquired several products from Lundbeck in January 2013 including Cosmegen. Cosmegen can be ordered through wholesalers or ASD Healthcare at 1-800-746-6273. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1064 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 86 Mercaptopurine Tablets May 21, 2014 Reason for the Shortage • Teva could not provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=997 Source link: http://www.ashp.org Levocarnitine Injection May 28, 2014 Reason for the Shortage • • • American Regent has levocarnitine injection on back order due to manufacturing delays. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Teva could not provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=968 Source link: http://www.ashp.org Vitamin E Aqueous Oral Solution May 29, 2014 Reason for the Shortage • Hospira is changing manufacturing sites from a 3rd party manufacturer to in-house manufacturing. This has caused a delay in production. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=965 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 87 Vinblastine Injection May 29, 2014 Reason for the Shortage • • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.1 Fresenius Kabi (formerly APP) had their product in short supply due to increased demand for the product and a manufacturing delay. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=883 Source link: http://www.ashp.org Synthetic Conjugated Estrogen May 29, 2014 Reason for the Shortage • • Teva could not provide a reason for the shortage. Premarin is not affected by this shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1087 Source link: http://www.ashp.org Chloramphenicol Sodium Succinate Injection May 29, 2014 Reason for the Shortage • • Fresenius Kabi has chloramphenicol injection on back order due to a raw material shortage. Fresenius Kabi is the sole supplier of chloramphenicol injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1068 Copyright© PerformRx, LLC 2013 All Rights Reserved 88 Ammonium Molybdate Injection May 29, 2014 Reason for the Shortage • • American Regent has ammonium molybdate injection on shortage due to manufacturing delays. American Regent is the sole supplier of ammonium molybdate injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1003 Source link: http://www.ashp.org Ascorbic Acid Injection June 02, 2014 Reason for the Shortage • • • American Regent had temporarily suspended distribution of most drug products in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. Hospira has discontinued all presentations of Cenolate injection and all supplies were depleted as of early-February, 2010. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=934 Source link: http://www.ashp.org Allopurinol Injection June 02, 2014 Reason for the Shortage • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Copyright© PerformRx, LLC 2013 All Rights Reserved 89 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=998 Source link: http://www.ashp.org Denileukin Diftitox Injection June 03, 2014 Reason for the Shortage • • Eisai is working to resolve a manufacturing problem. Eisai is the sole manufacturer of denileukin diftitox Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1009 Source link: http://www.ashp.org Choline Magnesium Trisalicylate June 03, 2014 Reason for the Shortage • • Caraco has discontinued their product. Product was recently seized by US Marshals due to good manufacturing practice violations (see news release for more information). Marlex could not provide a reason for their shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=556 Source link: http://www.ashp.org Reserpine Oral Tablets June 05, 2014 Reason for the Shortage • • Sandoz said the shortage is due to a delay in obtaining raw materials. There are no other manufacturers of reserpine tablets. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=975 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 90 Methazolamide Tablets June 05, 2014 Reason for the Shortage • • Sandoz cannot provide a reason for the shortage. Perrigo acquired Neptazane tablets and methazolamide tablets from Fera. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=901 Source link: http://www.ashp.org Acetazolamide Injection June 05, 2014 Reason for the Shortage • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=463 Source link: http://www.ashp.org Intravenous Fat Emulsion June 06, 2014 Reason for the Shortage • • • • Hospira recalled several lots of Liposyn II and Liposyn III presentations. Hospira has discontinued the Liposyn II presentations because the raw material is unavailable. Hospira has Liposyn III on shortage due to manufacturing delays. Baxter had Intralipid presentations on intermittent back order due to increased demand. Copyright© PerformRx, LLC 2013 All Rights Reserved 91 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=651 Source link: http://www.ashp.org Naproxen Oral Suspension June 11, 2014 Reason for the Shortage • • • Roxane discontinued their naproxen oral suspension in June 2013. Genentech could not provide a reason for the shortage. Palmetto acquired naproxen 25 mg/mL oral suspension in June 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1055 Source link: http://www.ashp.org Mesna Injection June 12, 2014 Reason for the Shortage • • Teva has a shortage of mesna injection due to manufacturing delays. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=642 Source link: http://www.ashp.org Atorvastatin Tablets June 12, 2014 Reason for the Shortage Copyright© PerformRx, LLC 2013 All Rights Reserved 92 • • • • In November 2012, Ranbaxy voluntarily recalled 41 lots of atorvastatin tablets due to possible contamination with very small glass particles. Ranbaxy resumed supply of atorvastatin tablets in late-March 2013. Ranbaxy has atorvastatin on shortage due to manufacturing delay. Apotex and Mylan Institutional could not provide a reason for the shortage. Watson discontinued all atorvastatin presentations in February 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=989 Source link: http://www.ashp.org Calcium Acetate Capsules June 16, 2014 Reason for the Shortage • • Fresenius Medical cannot provide a reason for the shortage. Hawthorne states the reason for the shortage was manufacturing delay. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1002 Source link: http://www.ashp.org Tesamorelin Injection June 23, 2014 Reason for the Shortage • • • • EMD Serono had Egrifta 2 mg vials on shortage due to manufacturing delays. EMD Serono discontinued Egrifta 1 mg vials in May 2013. Theratechnologies acquired Egrifta from EMD Serono in the spring of 2014. Theratechnologies has Egrifta 2 mg vials on shortage due to manufacturing delays. More information is available in a news release. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1065 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 93 Leuprolide Acetate 14-Day Kit June 23, 2014 Reason for the Shortage • • • Sandoz states the shortage was due to increased demand. Sandoz relaunched Leuprolide 1 mg/0.2 mL 2.8 mL injection in late-January, 2013. The product has a new NDC number. Teva states the shortage is due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=737 Source link: http://www.ashp.org Iron Dextran Injection June 23, 2014 Reason for the Shortage • American Regent cannot provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1069 Source link: http://www.ashp.org Pentostatin Injection June 24, 2014 Reason for the Shortage • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Copyright© PerformRx, LLC 2013 All Rights Reserved 94 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=874 Source link: http://www.ashp.org Labetalol Injection June 24, 2014 Reason for the Shortage • • • • • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that have already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Hospira had labetalol on shortage due to manufacturing delays and increased demand. Apotex discontinued their 4 mL vials (NDC 60505-0717-00) in February, 2010. The company could not provide a reason for the discontinuation. Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013. Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013 and 40 mL vials in February 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=397 Source link: http://www.ashp.org Cefotaxime Injection June 24, 2014 Reason for the Shortage • • • Fresenius Kabi discontinued all cefotaxime presentations in April 2011. Hospira has Claforan on shortage due to manufacturing delays. Baxter could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=826 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 95 Nalbuphine Injection June 26, 2014 Reason for the Shortage • • • Endo discontinued Nubain in 2008. Teva discontinued all nalbuphine injections in July, 2010. Hospira has nalbuphine on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=665 Source link: http://www.ashp.org Methylergonovine Maleate June 26, 2014 Reason for the Shortage • • Akorn could not provide a reason for the shortage of methylergonovine maleate injection. American Regent has methylergonovine maleate injection on back order due to manufacturing delays Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=906 Source link: http://www.ashp.org Echothiophate Powder for Ophthalmic Solution June 26, 2014 Reason for the Shortage • Pfizer is the only manufacturer of echothiophate powder for ophthalmic solution (Phospholine Iodide). Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=85 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 96 Hydrocortisone Sodium Succinate Injection June 30, 2014 Reason for the Shortage • • Hospira has A-Hydrocort on shortage due to requirements related to good manufacturing practices. Pfizer had Solu-Cortef on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=925 Source link: http://www.ashp.org Bumetanide Tablets June 30, 2014 Reason for the Shortage • • • Mylan Institutional discontinued bumetanide tablets in March 2014. Sandoz cannot provide a reason for the shortage. Teva cannot provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1073 Source link: http://www.ashp.org Vasopressin Injection July 02, 2014 Reason for the Shortage • • • • American Regent had temporarily suspended manufacture of most drug products including vasopressin injection in April, 2011.1 American Regent resumed manufacturing in Shirley, New York in early-May, 2011.2 American Regent recalled 17 lots of vasopressin in August, 2011 due to potential for decreased potency. JHP had Pitressin on shortage due to increased demand for the product.3 Copyright© PerformRx, LLC 2013 All Rights Reserved 97 • Fresenius Kabi (formerly APP) had vasopressin on shortage due to increased demand for the product.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=795 Source link: http://www.ashp.org Testosterone Cypionate Intramuscular Injection July 02, 2014 Reason for the Shortage • • • Paddock has testosterone on back order due to increased demand and shipping delays from their contract manufacturer. West-Ward had testosterone cypionate on shortage due to manufacturing delays. Sandoz discontinued testosterone cypionate 200 mg/mL 1 mL and 10 mL vials in September 2011. Sandoz discontinued final presentation in first half of 2012. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=638 Source link: http://www.ashp.org Ciprofloxacin Immediate-Release Tablets July 03, 2014 Reason for the Shortage • • • • • • • Ranbaxy has an FDA import ban on several of their products manufactured in India. Carlsbad Technology discontinued ciprofloxacin tablets in 2014. Marlex is unable to provide a reason for their shortage. Major discontinued their ciprofloxacin immediate-release tablets in February, 2010. Teva discontinued their ciprofloxacin immediate-release tablet, unit dose presentations in June, 2010. Schering has discontinued all Cipro immediate-release tablet presentations. UDL has discontinued all ciprofloxacin immediate-release 250 mg unit-dose tablets. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=572 Copyright© PerformRx, LLC 2013 All Rights Reserved 98 Cidofovir Injection July 03, 2014 Reason for the Shortage • • Gilead recalled one lot of Vistide on February 4, 2013, due to particulate matter in some vials. Mylan Institutional launched cidofovir injection in mid-March 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=994 Source link: http://www.ashp.org Terbutaline Sulfate Injection July 07, 2014 Reason for the Shortage • • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Akorn has discontinued terbutaline injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=808 Source link: http://www.ashp.org Empty Evacuated Containers July 08, 2014 Reason for the Shortage • • Baxter has empty evacuated containers on shortage due to supply constraints. B. Braun has evacuated glass containers on shortage due to increased demand for the product and raw material constraints Copyright© PerformRx, LLC 2013 All Rights Reserved 99 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=983 Source link: http://www.ashp.org Chromium (Chromic Chloride) Injection July 08, 2014 Reason for the Shortage • • • Hospira has chromium (chromic chloride) injection on shortage due to manufacturing delays. American Regent had temporarily suspended distribution of most drug products including chromium (chromic chloride) injection in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=943 Source link: http://www.ashp.org Caffeine and Sodium Benzoate Injection July 08, 2014 Reason for the Shortage • • • • American Regent had temporarily suspended manufacture of multiple drug products including caffeine and sodium benzoate injection in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. American Regent is the sole manufacturer of caffeine and sodium benzoate injection. Caffeine citrate injection is not affected by this shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=817 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 100 Ethambutol Tablets July 09, 2014 Reason for the Shortage • • • VersaPharm states the reason for the shortage is change in manufacturing facility. X-Gen could not provide a reason for the shortage. G&W Laboratories discontinued ethambutol tablets in mid-April 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=982 Source link: http://www.ashp.org Dihydroergotamine Mesylate Injection July 09, 2014 Reason for the Shortage • • • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Valeant cannot provide a reason for the shortage of dihydroergotamine mesylate injection. Paddock states the reason for the shortage is manufacturing delay. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1050 Source link: http://www.ashp.org Clarithromycin Immediate-Release Tablets July 09, 2014 Reason for the Shortage • Ranbaxy has an import ban on their products. Copyright© PerformRx, LLC 2013 All Rights Reserved 101 • • • • • Apotex import ban has been lifted, but the company is not marketing clarithromycin immediate-release tablets in the US. Mylan discontinued clarithromycin tablets in 2013. Teva could not provide a reason for the shortage. UDL discontinued clarithromycin 500 mg 100 count unit-dose in May 2013. Wockhardt has clarithromycin tablets on shortage due to regulatory delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=945 Source link: http://www.ashp.org Cephalexin Oral Suspension July 09, 2014 Reason for the Shortage • • • • Orchid/Karalax discontinued all cephalexin oral suspension products in the 3rd Quarter of 2013. Ranbaxy has an import ban on their cephalexin oral suspension products. Carlsbad Technology, Inc. discontinued all cephalexin oral suspension products in late2012 due manufacturing cost and shortage or raw materials. Teva could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1043 Source link: http://www.ashp.org Rifampin for Injection July 11, 2014 Reason for the Shortage • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Copyright© PerformRx, LLC 2013 All Rights Reserved 102 • • • Akorn discontinued rifampin in September 2013 due to shortage of raw material. Mylan Institutional acquired rifampin injection from Pfizer on December 7, 2013. Mylan Institutional discontinued rifampin injection in June 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=350 Source link: http://www.ashp.org Propranolol Injection July 11, 2014 Reason for the Shortage • • • • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Fresenius Kabi had propranolol injection available but with short-expiration dating. Sandoz cannot provide a reason for the shortage. West-Ward has propranolol injection on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1091 Source link: http://www.ashp.org Sodium Thiosulfate Injection July 14, 2014 Reason for the Shortage • • • American Regent has recently upgraded their manufacturing plant. Product will become available in stages as production resumes. Hope Pharmaceutical received FDA approval of their sodium thiosulfate product in February, 2012. Hope Pharmaceutical has the only FDA approved product of sodium thiosulfate. Hope also has Nithiodote available, a combination of sodium thiosulfate and sodium nitrite. Copyright© PerformRx, LLC 2013 All Rights Reserved 103 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=766 Source link: http://www.ashp.org Lactated Ringer’s Injection Bags July 14, 2014 Reason for the Shortage • • • Baxter has lactated ringer’s on shortage due to increased demand. BBraun has lactated ringer’s on allocation due to increased demand. Hospira cites increased demand as the reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1078 Source link: http://www.ashp.org Fluconazole Injection July 14, 2014 Reason for the Shortage • • • • Teva has fluconazole injection on shortage due to manufacturing delays. Pfizer had fluconazole injection on shortage due to manufacturing delays related to labeling changes. West-Ward has fluconazole injection on shortage due to manufacturing delays. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=644 Source link: http://www.ashp.org Ezetimibe and Atorvastatin Tablets July 14, 2014 Copyright© PerformRx, LLC 2013 All Rights Reserved 104 Reason for the Shortage • In January 2014, Merck recalled all Liptruzet lots from wholesalers due to packaging defects in the outer laminate foil pouches. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1084 Source link: http://www.ashp.org Citric acid and Potassium Citrate Oral July 14, 2014 Reason for the Shortage • Cypress Pharmaceuticals has Cytra-K crystals on back order due to a raw material supply issue. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1080 Source link: http://www.ashp.org Amphotericin B Cholesteryl Sulfate Complex Injection July 14, 2014 Reason for the Shortage • • • Kadmon had acquired Three Rivers Pharmaceuticals in October 2010 and Amphotec was part of the product portfolio. Kadmon recently sold Amphotec to Alkopharma. Alkopharma is the sole supplier of amphotericin b cholesteryl sulfate lipid complex. The contracted manufacturer of Amphotec was Ben Venue Laboratories. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Copyright© PerformRx, LLC 2013 All Rights Reserved 105 • The shortage of amphotericin b cholesteryl sulfate lipid complex is not affecting other amphotericin formulations. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=884 Source link: http://www.ashp.org Aminophylline Injection July 14, 2014 Reason for the Shortage • • • • • American Regent had temporarily suspended distribution of most drug products in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. Hospira states that the shortage is due to manufacturing delays. Hospira discontinued aminophylline ampules in September, 2011. Theophylline injection is available from BBraun and may be affected by this shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=705 Source link: http://www.ashp.org Cisatracurium Injection July 15, 2014 Reason for the Shortage • • Sandoz could not provide a reason for the shortage. Nimbex injection is on shortage due to increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1072 Source link: http://www.ashp.org Tetracycline Capsules July 17, 2014 Copyright© PerformRx, LLC 2013 All Rights Reserved 106 Reason for the Shortage • • • • Due to the shortage, combination products that contain oral tetracycline may be affected as well. Heritage launched tetracycline capsules in October 2013. Teva states tetracycline capsules are unavailable due to a raw material shortage. Watson discontinued tetracycline capsules in October 2013. The company could not provide a reason for the discontinuation. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=816 Source link: http://www.ashp.org Prednisone Tablets July 17, 2014 Reason for the Shortage • • • • • Cadista states the shortage is due to a raw materials shortage. Perrigo discontinued prednisone tablets in 2013. Roxane and Watson could not provide a reason for the shortage. Qualitest discontinued prednisone 20 mg tablets in August 2013. West-Ward states the reason for the shortage is manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=930 Source link: http://www.ashp.org Methotrexate Tablets July 17, 2014 Reason for the Shortage • • Major discontinued methotrexate tablets in 2013. Mylan could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=961 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 107 Doxorubicin Liposomal Injection July 17, 2014 Reason for the Shortage • • • • Janssen Products, LP states the shortage is due to manufacturing issues. Janssen Products, LP has updates with information about the shortage on the Doxil website that is updated regularly.1-3 Janssen is working to transition Doxil manufacturing to additional suppliers. A temporary solution to this shortage was to use areas of the Ben Venue Laboratories facility available for production and other partners to complete the manufacturing process. FDA exercised regulatory discretion and approved an additional lot of 2 mg/mL 10 mL (20 mg) vials. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Caraco launched generic doxorubicin liposomal injection in mid-March 2013 and can supply the market with their presentations. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=806 Source link: http://www.ashp.org Mirtazapine Tablets July 18, 2014 Reason for the Shortage • • • • • Actavis (Watson) cannot provide a reason for the shortage. Actavis discontinued their mirtazapine 15 mg oral disintegrating tablets in May 2014. Greenstone discontinued all remaining mirtazapine presentations in December 2013. Sandoz discontinued their mirtazapine presentations in early-2014. Teva discontinued various unit dose presentations throughout 2013, including mirtazapine. Teva could not provide a reason for the shortage Copyright© PerformRx, LLC 2013 All Rights Reserved 108 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1066 Source link: http://www.ashp.org Vincristine Injection July 21, 2014 Reason for the Shortage • • Hospira states the shortage was due to manufacturing delays.1 Teva states vincristine injection is on shortage due to manufacturing delays.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=42 Source link: http://www.ashp.org Sulfacetamide and Prednisolone Ophthalmic Ointment July 21, 2014 Reason for the Shortage • • Allergan states the reason for shortage was difficulty in obtaining the raw materials needed for manufacturing. Allergan is the sole supplier of sulfacetamide 10% and prednisolone 0.2% ophthalmic ointment and ophthalmic suspension. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1033 Source link: http://www.ashp.org Dibucaine Ointment July 21, 2014 Reason for the Shortage • • • Perrigo and Fougera cannot provide a reason for the shortage. Geritrex introduced dibucaine 1% ointment in March 2014. Novartis divested the rights for all Nupercainal ointment products to Ducere Pharma in 2013. Copyright© PerformRx, LLC 2013 All Rights Reserved 109 • These products are available Over-The-Counter. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1074 Source link: http://www.ashp.org Atropine Sulfate Injection July 21, 2014 Reason for the Shortage • • • American Regent had temporarily suspended manufacture of most drug products in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. Hospira states the shortage is due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=814 Source link: http://www.ashp.org Atracurium Injection July 21, 2014 Reason for the Shortage • • • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure. Hospira launched atracurium in mid-2013. Sagent as atracurium on allocation due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=872 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 110 Nicardipine Hydrochloride Injection July 22, 2014 Reason for the Shortage • • • • • • • Cornerstone Therapeutics discontinued Cardene ampules in March 2014. The company could not provide a reason for the discontinuation. Teva recalled 4 lots nicardipine injection because the product did not meet purity specifications. The recalled lots are 31302508B, 31302510B, 31302957B, 31303195B. Teva discontinued nicardipine injection in September, 2010. American Regent had temporarily suspended distribution of all drug products in April, 2011. American Regent resumed manufacturing in Shirely, New York in early-May, 2011. Mylan Institutional could not provide a reason for the shortage. Wockhardt has nicardipine on shortage due to an FDA import alert. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=31 Source link: http://www.ashp.org Ethiodized Oil July 23, 2014 Reason for the Shortage • • • Savage / Nycomed no longer manufactures Ethiodol solution for injection due to a marketing decision.1 In cooperation with FDA, Guerbet was importing Lipiodol Ultra-Fluide.2,3 Guerbet received FDA approval of Lipiodol in April 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=618 Source link: http://www.ashp.org Desmopressin Injection July 23, 2014 Reason for the Shortage Copyright© PerformRx, LLC 2013 All Rights Reserved 111 • • Teva and Hospira have desmopressin injection on shortage due to manufacturing delays. Sanofi could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1010 Source link: http://www.ashp.org Barium Sulfate Oral Suspension July 23, 2014 Reason for the Shortage • • Bracco Diagnostics states the reason for the shortage is manufacturing delay, as well as increased demand. Bracco Diagnostics has provided a customer letter detailing the reason for the shortage and barium sulfate presentations affected.1 Bracco discontinued multiple products in August 2013 in order to streamline their product portfolio. Table 1 summarizes the barium products that were discontinued. Bracco has provided an updated product portfolio detailing the product changes and the recommended alternate products.1 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=963 Source link: http://www.ashp.org Rabies Immune Globulin July 25, 2014 Reason for the Shortage • Sanofi Pasteur states the reason for the shortage is increased demand and manufacturing delay.1 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=331 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 112 Procainamide Hydrochloride Injection July 25, 2014 Reason for the Shortage • • Hospira had procainamide injection on shortage due to manufacturing delays. There are no other manufacturers of procainamide injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=868 Source link: http://www.ashp.org Multiple Vitamins for Infusion July 25, 2014 Reason for the Shortage • • Hospira states the shortage is due to manufacturing delays. Baxter states the reason for the shortage is manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=831 Source link: http://www.ashp.org Lidocaine with Epinephrine Injection July 25, 2014 Reason for the Shortage • • Hospira has lidocaine with epinephrine presentations on shortage due to manufacturing delays. Fresenius Kabi (formerly APP) has Xylocaine with epinephrine presentations on shortage due to increased demand for the product. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=860 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 113 Copper Injection July 25, 2014 Reason for the Shortage • • • American Regent had temporarily suspended manufacture of most drug products in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. Hospira had cupric chloride on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=946 Source link: http://www.ashp.org Chorionic Gonadotropin (Human) Injection July 25, 2014 Reason for the Shortage • Merck (formerly Schering-Plough) states their product is on allocation to prevent use in the gray market. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=382 Source link: http://www.ashp.org Chloroprocaine Injection July 25, 2014 Reason for the Shortage • • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including chloroprocaine injection. Hospira discontinued chloroprocaine injection in January, 2012 due to inability to obtain raw materials. All supply was depleted in January. Fresenius Kabi (formerly APP) has transitioned from 1 count presentations to 25 count sizes. All 1 count presentations were depleted in early 2012. Copyright© PerformRx, LLC 2013 All Rights Reserved 114 • Fresenius Kabi (formerly APP) had Nesacaine on shortage from depletion of raw materials due increased demand for the product. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=849 Source link: http://www.ashp.org Ammonium Chloride Injection July 25, 2014 Reason for the Shortage • • Hospira states the shortage of ammonium chloride is due to manufacturing delays. Hospira is the sole manufacturer of ammonium chloride injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=933 Source link: http://www.ashp.org Torsemide Injection July 29, 2014 Reason for the Shortage • • Roche discontinued Demadex injection for business reasons. Demadex tablets are not affected by this shortage. American Regent has torsemide on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=344 Source link: http://www.ashp.org Succinylcholine chloride Injection July 29, 2014 Reason for the Shortage • Hospira had Quelicin on shortage due to manufacturing delays.1 Copyright© PerformRx, LLC 2013 All Rights Reserved 115 • Sandoz had Anectine on shortage due to extra quality reviews.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=582 Source link: http://www.ashp.org Selenium Injection July 29, 2014 Reason for the Shortage • American Regent has selenium injection on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=784 Source link: http://www.ashp.org Ranitidine Injection July 29, 2014 Reason for the Shortage • • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired ranitidine injection from Bedford in July 2014.1 Covis has Zantac on shortage due to capacity issues at the manufacturer.2 Oral ranitidine products are not affected by this shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=820 Source link: http://www.ashp.org Phenylephrine Hydrochloride Injection July 29, 2014 Reason for the Shortage • American Regent has phenylephrine injection on shortage due to increased demand for the product. Copyright© PerformRx, LLC 2013 All Rights Reserved 116 • Sandoz could not provide a reason for the phenylephrine injection shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=184 Source link: http://www.ashp.org Papaverine Injection July 29, 2014 Reason for the Shortage • • • Bedford and Sandoz have discontinued their papaverine presentations.1,2 American Regent has papaverine on shortage due to manufacturing delays.3 American Regent is the sole supplier of papaverine.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=781 Source link: http://www.ashp.org Methylene Blue Injection July 29, 2014 Reason for the Shortage • • Akorn had methylene blue on back order due to increased demand for the product. 1 American Regent has methylene blue on back order due to manufacturing delays.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=27 Source link: http://www.ashp.org Indigo Carmine Injection July 29, 2014 Reason for the Shortage • • American Regent has indigo carmine on back order due to manufacturing delays.1 Akorn has discontinued production of indigo carmine due to shortage of raw material. Akorn is looking for a new raw material supplier.2 Copyright© PerformRx, LLC 2013 All Rights Reserved 117 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=861 Source link: http://www.ashp.org Electrolyte Concentrate July 29, 2014 Reason for the Shortage • American Regent has Nutrilyte and Nutrilyte on back order due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1054 Source link: http://www.ashp.org Cyanocobalamin Injection July 29, 2014 Reason for the Shortage • • American Regent has cyanocobalamin injection on shortage due to manufacturing delays.1 Fresenius Kabi has cyanocobalamin injection on shortage due to increased demand for the product.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=947 Source link: http://www.ashp.org Thiotepa for Injection July 30, 2014 Reason for the Shortage • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including thiotepa injection. FDA is allowing temporary importation of Tepadina (thiotepa), from Adienne Srl in Italy. Product may be ordered directly through Adienne Srl. The solution is similar in Copyright© PerformRx, LLC 2013 All Rights Reserved 118 • • formulation to US thiotepa. The main differences between the two products are listed below: o Tepadina comes in 15 mg and 100 mg vials while the US thiotepa from Bedford only comes in a 15 mg vial. Reconstitution of the products should still yield a final concentration of 10 mg/mL and therefore use caution in choosing vial size and volume of diluent. o Tepadina is indicated for different uses and therefore different dosing regimens are on the Europe labeling compared to US labeling, but it is the same product as in the US. o The bar coding for the Italian product will not provide correct information to bar code readers since the manufacturing code is not an NDC number. More information on the product packaging and ordering procedures can be found online. Adienne Srl is supplying Tepadina directly to hospitals and not through wholesalers. Orders can be placed directly with Adienne. Orders are shipped Monday through Wednesday to ensure product can arrive prior to the weekend to prevent temperature deviations. There are no other manufacturers of thiotepa for injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=589 Source link: http://www.ashp.org Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine July 30, 2014 Reason for the Shortage • • • • • Sanofi-Pasteur has Adacel is in short supply due to manufacturing delays. This product is also known as adult tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine.1 Sanofi-Pasteur is in the process of implementing new NDC numbers for vaccine products.1 GlaxoSmithKline has available Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Boostrix). The 1 count Boostrix syringe is no longer made.2 GlaxoSmithKline has Boostrix on shortage due to increased demand.2 Adult Tetanus and Diphtheria Toxoids Adsorbed (Td) (Tenivac, Sanofi-Pasteur) is not affected by this shortage.1 Copyright© PerformRx, LLC 2013 All Rights Reserved 119 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1051 Source link: http://www.ashp.org Morphine Injections July 30, 2014 Reason for the Shortage • • • • • Fresenius Kabi (formerly APP) states the shortage is due to a change in manufacturing sites. Hospira states the shortage is due to manufacturing delays. Hospira discontinued preservative-containing Carpuject syringes in August, 2012 and replaced them with preservative-free Carpuject syringes. West-Ward states the shortage was due to increased demand for product. West-Ward changed old Baxter to new West-Ward NDC codes in early 2012. IMS (Amphastar) discontinued morphine 1 mg/mL 10 mL Luer-lock syringes in March, 2012 due to low demand for the product. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=664 Source link: http://www.ashp.org Fenoldopam Mesylate Injection July 30, 2014 Reason for the Shortage • Hospira has Corlopam on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1031 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 120 Buprenorphine Sublingual Tablets July 30, 2014 Reason for the Shortage • Teva could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1030 Source link: http://www.ashp.org Amifostine Injection July 30, 2014 Reason for the Shortage • • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired amifostine injection from Bedford in July 2014. West-Ward is actively marketing amifostine injection. Caraco could not provide a reason for the shortage. Medimmune discontinued brand name Ethyol 500 mg injection in August, 2009. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=980 Source link: http://www.ashp.org Reteplase Injection July 31, 2014 Reason for the Shortage • Cornerstone Therapeutics acquired EKR Therapeutics in June 2012. EKR Therapeutics had previously purchased Retavase from PDL BioPharma. Cornerstone is seeking FDA approval of a new supplier of the active pharmaceutical ingredient for Retevase. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=569 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 121 Promethazine Injection July 31, 2014 Reason for the Shortage • • • Teva states the shortage is due to manufacturing delays. West-Ward states the shortage was due to manufacturing delays. The company has also changed the NDC numbers for products that were formerly Baxter products. Hospira states the shortage is due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=654 Source link: http://www.ashp.org Polymyxin B Sulfate Injection July 31, 2014 Reason for the Shortage • • • Fresenius Kabi (formerly APP) could not provide a reason for the shortage. Sagent suspended manufacturing of Polymyxin B sulfate injection in October, 2012. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including polymyxin B sulfate injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=974 Source link: http://www.ashp.org Benztropine Injection July 31, 2014 Reason for the Shortage • • American Regent has benztropine injection on back order due to manufacturing delays. Fresenius Kabi USA recalled benztropine injection due to potential for glass particles in the vials. Product may have been under APP or Nexus labels. Detailed information on the recall can be found online. Copyright© PerformRx, LLC 2013 All Rights Reserved 122 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1042 Source link: http://www.ashp.org Alcohol Dehydrated Injection (Ethanol) July 31, 2014 Reason for the Shortage • • American Regent has alcohol dehydrated on back order due to manufacturing delays. Hospira and Consolidated Midland discontinued all injectable alcohol dehydrated products. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=778 Source link: http://www.ashp.org Vecuronium Bromide Injection August 01, 2014 Reason for the Shortage • • • • • Hospira states the shortage is due to manufacturing delays.1,2 Teva states the shortage is due to manufacturing delays.3 Pfizer sold vecuronium injection to Mylan Institutional in December 2013.4,5 Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.6 Sagent temporarily suspended the manufacture of vecuronium 10 mg and 20 mg vials.8 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=490 Source link: http://www.ashp.org Tolterodine Tartrate Extended Release Capsules August 01, 2014 Reason for the Shortage Copyright© PerformRx, LLC 2013 All Rights Reserved 123 • • Mylan discontinued tolterodine extended release 2 mg and 4 mg capsules in 90 count bottles in April 2014. Teva could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1114 Source link: http://www.ashp.org Sulfamethoxazole and Trimethoprim Oral Suspension August 01, 2014 Reason for the Shortage • • • Aurobindo could not provide a reason for the shortage. Hi-Tech Pharmacal discontinued all presentations of sulfamethoxazole and trimethoprim oral suspension in June 2014. Pharmaceutical Associated discontinued sulfamethoxazole and trimethoprim oral suspension in September 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1109 Source link: http://www.ashp.org Sodium Chloride 0.9% Injection Bags August 01, 2014 Reason for the Shortage • • • • Baxter has 0.9% sodium chloride on shortage due to increased demand.1 BBraun had 0.9% sodium chloride on allocation due to increased demand.2 Hospira cites increased demand as the reason for the shortage.3 In cooperation with the FDA, Fresenius Kabi is providing 0.9% sodium chloride to the US market to help alleviate the national shortage. This 0.9% sodium chloride is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG. There will be presentations available with Australian/English label and the package insert is the same for all imported presentations.4,5 Copyright© PerformRx, LLC 2013 All Rights Reserved 124 • In cooperation with the FDA, Baxter is providing imported 0.9% sodium chloride to the US market to help alleviate the national shortage. This 0.9% sodium chloride in Viaflo containers is manufactured in Spain by Baxter. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=993 Source link: http://www.ashp.org Secretin Injection August 01, 2014 Reason for the Shortage • • ChiRhoClin is qualifying a manufacturing site. ChiRhoClin is working with FDA to allow the release of ChiRhoStim lot # 0636149. This lot was produced at a new manufacturing site that has not been approved by FDA. Please see the Dear Health Care Provider letter. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=913 Source link: http://www.ashp.org Phosphorus Oral Supplements August 01, 2014 Reason for the Shortage • Cypress Pharmaceuticals has Phos-Nak Powder on back order due to manufacturing delays.1 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1102 Source link: http://www.ashp.org Metronidazole Injection August 01, 2014 Reason for the Shortage Copyright© PerformRx, LLC 2013 All Rights Reserved 125 • • Hospira has metronidazole injection on back order due to manufacturing delays. Baxter, BBraun, and Claris are allocating metronidazole injection due to increased demand for the product. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=643 Source link: http://www.ashp.org Magnesium Sulfate Injection August 01, 2014 Reason for the Shortage • • • American Regent has magnesium sulfate on shortage due to manufacturing delays. Fresenius Kabi (formerly APP) had magnesium sulfate injection on shortage due to increased demand for the product. Hospira has magnesium sulfate injection on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=757 Source link: http://www.ashp.org Heparin Sodium Injection August 01, 2014 Reason for the Shortage • • • • • • FDA has issued import bans against 22 Chinese manufacturers of heparin due to inadequate good manufacturing practices (GMPs).1 West-Ward obtained five presentations of the heparin sodium injection from Baxter in September, 2011. Baxter only retained two large volume heparin presentations. All other Baxter presentations have been discontinued.2,3 Fresenius Kabi (formerly APP) reports that heparin products are on back order due to increased demand for the product.4 Hospira states the shortage of heparin vials is due to manufacturing delays.5 Covidien and B. Braun could not provide a reason for the shortage.9,11 Sagent has heparin on shortage due to increased demand for the product.6 Copyright© PerformRx, LLC 2013 All Rights Reserved 126 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=387 Source link: http://www.ashp.org Doxorubicin Injection August 01, 2014 Reason for the Shortage • • • • • Ben Venue stopped production in is plant in Bedford, Ohio, and closed in July 2014. Ben Venue supplied multiple sterile injectable products for Bedford Laboratories.1 Pfizer had doxorubicin solution for injection on shortage due to shipping delays.5 Sagent introduced doxorubicin injection in November 2013.6 Mylan Institutional acquired doxorubicin lyophilized powder from Pfizer on December 6, 2013.7 Teva could not provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=464 Source link: http://www.ashp.org Dobutamine Injection August 01, 2014 Reason for the Shortage • • • Baxter had dobutamine on back order due to increased demand and manufacturing constraints. Hospira has dobutamine on shortage due increased demand for the product. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including dobutamine injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=929 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 127 Dexamethasone Sodium Phosphate August 01, 2014 Reason for the Shortage • • • • • American Regent has dexamethasone sodium phosphate on shortage due to manufacturing delays.1 Fresenius Kabi (formerly APP) states the dexamethasone sodium phosphate shortage was due to supply and demand issues.2 Baxter could not provide a reason for the shortage. Baxter sold several products to West-Ward in mid-2011.3 West-Ward had dexamethasone sodium phosphate injection on shortage due to increased demand.4 Pfizer divested all dexamethasone presentation to Mylan Institutional on December 6, 2013.4,5 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=751 Source link: http://www.ashp.org Calcium Gluconate Injection August 01, 2014 Reason for the Shortage • • • American Regent has calcium gluconate on shortage due to manufacturing delays. Fresenius Kabi had calcium gluconate on shortage due to increase demand for the product. American Regent has issued a statement that all lots of calcium gluconate may contain glass particles and filters must be used. Do not use if there are visible glass particles and filter all other product. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=48 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 128 Amikacin Injection August 01, 2014 Reason for the Shortage • • • • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired amikacin injection from Bedford in July 2014.1 Hospira discontinued amikacin in May, 2010 due to a raw material shortage.2 Teva’s product was unavailable due to manufacturing delays.3 Sandoz discontinued Amikin injection in 2006.4 Heritage launched amikacin injection in March 2014.5 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=501 Source link: http://www.ashp.org Tamoxifen Tablets August 04, 2014 Reason for the Shortage • • Teva and Mylan could not provide a reason for the shortage. Actavis could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1071 Source link: http://www.ashp.org Mitomycin Injection August 04, 2014 Reason for the Shortage • • Ben Venue has stopped production in its plant in Bedford, Ohio and close in July 2014. 1,2 Accord states the reason for the shortage was increased demand.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=433 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 129 Lidocaine Injection August 04, 2014 Reason for the Shortage • • • • • • Hospira has lidocaine presentations on shortage due to manufacturing delays. Fresenius Kabi, USA (formerly APP) has Xylocaine and lidocaine presentations on shortage due to increased demand for the product. Amphastar had lidocaine 2% emergency syringes on shortage due to increased demand for the product. BBraun has lidocaine and dextrose premixed bags on shortage due to increased demand for the product. Baxter discontinued two lidocaine and dextrose premixed bag presentations in March, 2012. AuroMedics introduced lidocaine injection in February 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=859 Source link: http://www.ashp.org Ketamine Injection August 04, 2014 Reason for the Shortage • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including ketamine injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=592 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 130 Haemophilus B Conjugate Vaccine August 04, 2014 Reason for the Shortage • • • Sanofi Pasteur had ActHIB in short supply due to the shortage of other combination vaccines (eg, Pentacel®).1 GlaxoSmithKline cannot provide a reason for the shortage of Hiberix but it has not been manufactured since 2011.2 Merck announced in March 2014 plans to discontinue Comvax vaccine. Product will no longer be available directly from Merck after December 31, 2014.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1052 Source link: http://www.ashp.org Azithromycin Injection August 04, 2014 Reason for the Shortage • • • • Fresenius Kabi could not provide a reason for the shortage. Hospira has azithromycin injection on shortage due to increased demand. Sagent has azithromycin injection on shortage due to increased demand. Pfizer discontinued Zithromax 500 mg vial with Vial-Mate Adaptor in January 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=936 Source link: http://www.ashp.org Azathioprine Injection August 04, 2014 Reason for the Shortage • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired azathioprine injection from Bedford in July 2014. There are no other manufacturers of azathioprine injection. Copyright© PerformRx, LLC 2013 All Rights Reserved 131 • The oral presentations are not affected by this shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=935 Source link: http://www.ashp.org Aspirin Tablets (Buffered) August 04, 2014 Reason for the Shortage • • • • • • • Novartis has temporarily suspended manufacture of multiple drug products that were manufactured at the Lincoln facility including Bufferin and Ascriptin Tablets. Novartis voluntarily recalled all lots of Bufferin Tablets with expiration dates of December 20, 2013 or earlier. Novartis divested the rights for all Bufferin products to Ducere Pharma in early-2013. Ducere Pharma re-introduced Bufferin tablets in late 2013. Medique Products discontinued their buffered aspirin presentations in May, 2012. Major states the shortage was due to increased demand for the product. Teva discontinued their buffered aspirin products late 2009 and early 2010. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=950 Source link: http://www.ashp.org Adenosine Injection August 04, 2014 Reason for the Shortage • • • • • Akorn launched adenosine 3 mg/mL 2 mL vials 25 count in April 2013. Astellas had Adenoscan on back order due to increased demand. This back order is now resolved. Adenoscan is used for diagnostic purposes as an adjunct to thallium-201 myocardial perfusion scintigraphy. Adenocard and generic adenosine products are labeled for use in paroxysmal supraventricular tachycardia. Ben Venue has stopped production in its plant in Bedford, Ohio and closed in July 2014. Sagent has adenosine vials on shortage due to manufacturing delay. Teva has discontinued their adenosine injection. Copyright© PerformRx, LLC 2013 All Rights Reserved 132 • Wockhardt discontinued their adenosine 3 mg/mL 2 mL and 4 mL syringes. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=976 Source link: http://www.ashp.org Morrhuate Sodium Injection August 05, 2014 Reason for the Shortage • American Regent has morrhuate sodium injection on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=903 Source link: http://www.ashp.org Glycopyrrolate Injection August 05, 2014 Reason for the Shortage • • American Regent had glycopyrrolate on shortage due to manufacturing delays. West-Ward is focusing production on generic glycopyrrolate. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=385 Source link: http://www.ashp.org Ticarcillin Clavulanate August 06, 2014 Reason for the Shortage • • GlaxoSmithKline could not provide a reason for the shortage. GlaxoSmithKline discontinued Timentin 3.1 gram ADD-Vantage vials in late-2012. Copyright© PerformRx, LLC 2013 All Rights Reserved 133 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=802 Source link: http://www.ashp.org Sodium Chloride Concentrated Solution for Injection August 06, 2014 Reason for the Shortage • • • • American Regent discontinued 23.4% sodium chloride 30 mL and 100 mL presentations in 2012. Baxter discontinued their sodium chloride 250 mL presentation in 2008. Fresenius Kabi (formerly APP) has sodium chloride concentrated solution on shortage due to increased demand. Fresenius Kabi discontinued 14.6% sodium chloride 20 mL vials in February 2013. Hospira has 14.6% and 23.4% sodium chloride solutions for injection on shortage due to manufacturing delays. Hospira discontinued sodium chloride 14.6% solution 250 mL vials in February 2011. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=724 Source link: http://www.ashp.org Sincalide Injection August 06, 2014 Reason for the Shortage • • Bracco Diagnostics has Kinevac on shortage due to manufacturing delays. There are no approved alternatives to Kinevac for the labeled indications Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1032 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 134 Potassium Chloride Injection August 06, 2014 Reason for the Shortage • • Hospira states the reason for the shortage is manufacturing delays. Fresenius Kabi and Baxter could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=696 Source link: http://www.ashp.org Oxytocin Injection August 06, 2014 Reason for the Shortage • • • Fresenius Kabi, USA (formerly APP) states the shortage is due to increased demand. Par Sterile Products (formerly JHP) discontinued generic oxytocin injection in July 2014. West-Ward states the shortage is due to stock becoming short-dated. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=876 Source link: http://www.ashp.org Metoprolol Injection August 06, 2014 Reason for the Shortage • • • American Regent has metoprolol injection on shortage due to manufacturing delays.1,2 Fresenius Kabi, Hospira and Sagent state the shortage was due to increased demand for the product.3,4,7 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.5,6 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=813 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 135 Isosorbide Dinitrate Immediate Release Tablets August 06, 2014 Reason for the Shortage • • • Major discontinued isosorbide dinitrate 5 mg immediate release tablets in April 2012. Major discontinued isosorbide dinitrate 10 mg immediate release tablets in April 2013. Major discontinued isosorbide dinitrate 20 mg immediate release tablets in June 2013. West-Ward discontinued several isosorbide dinitrate immediate release tablet presentations in December 2013. West-Ward states the shortage was due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=909 Source link: http://www.ashp.org Indocyanine Green August 06, 2014 Reason for the Shortage • • Akorn states the reason for the shortage is increased demand. Hub Pharmaceuticals cannot provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1107 Source link: http://www.ashp.org Hydromorphone Hydrochloride Injection August 06, 2014 Reason for the Shortage • Hospira has hydromorphone injection on shortage due to manufacturing delays Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=856 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 136 Gentamicin injection August 06, 2014 Reason for the Shortage • • • Hospira has gentamicin on shortage due to manufacturing delays1 Fresenius Kabi (formerly APP) had gentamicin on shortage due to increased demand. Fresenius Kabi discontinued their 10 mg/mL 2 mL multi-dose vial in mid-20112 Baxter has gentamicin on shortage due to increased demand.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=728 Source link: http://www.ashp.org Fentanyl Injection August 06, 2014 Reason for the Shortage • • • • West-Ward acquired Baxter’s fentanyl injection products in May, 2011. The company began changing NDC numbers in July, 2012.1,2 West-Ward states the shortage was due to a manufacturing delay for the fentanyl 50 mcg/mL 20 mL ampules. The 20 mL vials were in short supply due to increased demand.1 Hospira states the shortage is due to increased demand and manufacturing delays including quality improvement activities. Hospira is increasing production of the ampules to help meet the demand. 3 Akorn launched Sublimaze injection in late-March, 2012.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=647 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 137 Epinephrine Injection August 06, 2014 Reason for the Shortage • • • • • American Regent has epinephrine on shortage due to manufacturing delays. Hospira has epinephrine syringes on shortage due to manufacturing delays. JHP states the reason for the shortage was due to increased demand. JHP discontinued three epinephrine presentations in late-2013. Amphastar states the shortage is due to increased demand. Amphastar changed the NDC numbers of their epinephrine products in November 2012. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=685 Source link: http://www.ashp.org Enalaprilat Injection August 06, 2014 Reason for the Shortage • • • • Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014. Teva has discontinued both of their products. Hospira has enalaprilat injection on shortage due to manufacturing delays. West-Ward has enalaprilat injection on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=587 Source link: http://www.ashp.org Droperidol Injection August 06, 2014 Reason for the Shortage • • American Regent has droperidol injection on back order due to manufacturing delays. Hospira has droperidol on back order due to shortage of raw material. Copyright© PerformRx, LLC 2013 All Rights Reserved 138 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=818 Source link: http://www.ashp.org Dipyridamole Injection August 06, 2014 Reason for the Shortage • • Bedford discontinued dipyridamole injection in May, 2011 to concentrate on the manufacturing of other products. Teva has temporarily discontinued their 2 mL and 10 mL products in order to increase the package sizes. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=465 Source link: http://www.ashp.org Dexpanthenol Injection August 06, 2014 Reason for the Shortage • • American Regent has dexpanthenol injection on shortage due to manufacturing delays. There are no other suppliers of dexpanthenol injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1103 Source link: http://www.ashp.org Calcitriol Injection August 06, 2014 Reason for the Shortage • • • Akorn has calcitriol injection on shortage due to increased demand for the product. American Regent has calcitriol on back order due to manufacturing delays. Abbott discontinued Calcijex in April 2012. Copyright© PerformRx, LLC 2013 All Rights Reserved 139 • • • West-Ward discontinued their calcitriol injection in May, 2011. Calcitriol capsule and oral solution presentations are available from multiple manufacturers. Fresenius Kabi (formerly APP) discontinued calcitriol injection in January 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=940 Source link: http://www.ashp.org Bupivacaine with epinephrine Injection August 06, 2014 Reason for the Shortage • • Fresenius Kabi (formerly APP) has Sensorcaine with epinephrine on shortage due to increased demand for the product. Hospira has bupivacaine with epinephrine and Marcaine with epinephrine on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=937 Source link: http://www.ashp.org Zinc Injection August 07, 2014 Reason for the Shortage • • • • Hospira states the shortage of zinc chloride injection is due to manufacturing delays. Hospira is the only manufacturer of zinc chloride injection. American Regent states the shortage of zinc sulfate injection is due to manufacturing delays. FDA is allowing temporary importation of zinc gluconate trihydrate 1 mg/mL 10 mL vials from Aguettant Laboratories in France. This product is being distributed through Baxter Healthcare. The labeling will come in the original container which is in French. Information translated into English along with a table comparing the US and French products can be found in the Dear Healthcare Professional Letter. Copyright© PerformRx, LLC 2013 All Rights Reserved 140 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=777 Source link: http://www.ashp.org Verapamil Injection August 07, 2014 Reason for the Shortage • • Hospira states the shortage is due to manufacturing delays. Hospira is the sole supplier if verapamil injection Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=744 Source link: http://www.ashp.org Sodium Phosphate Injection August 07, 2014 Reason for the Shortage • • • • • American Regent has sodium phosphate injection on back order due to manufacturing delays.1,2 American Regent has issued a statement that all lots of sodium phosphate have potential for crystallization. Do not use if any particles are present.3,4 Hospira has sodium phosphate injection on shortage due to manufacturing delays. 5 In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG.6 Fresenius Kabi launched sodium phosphate injection in mid-January 2014.7 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=770 Source link: http://www.ashp.org Potassium Acetate Injection August 07, 2014 Reason for the Shortage Copyright© PerformRx, LLC 2013 All Rights Reserved 141 • • • Hospira states the shortage was due to manufacturing delays. Hospira and American Regent discontinued potassium acetate 2 meq/mL 100 mL bulk packages. American Regent has potassium acetate on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=668 Source link: http://www.ashp.org Methyldopate Injection August 07, 2014 Reason for the Shortage • • American Regent has methyldopate injection on shortage due to manufacturing delays. There are no other suppliers of methyldopate injection Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=844 Source link: http://www.ashp.org Memantine Hydrochloride August 07, 2014 Reason for the Shortage • • • Forest states the reason for the shortage of Namenda XR capsules is manufacturing delay. Forest plans to discontinue all Namenda immediate-release tablets in Fall 2014. The discontinuation date was extended from August 2014 to Fall 2014 to ensure adequate supplies of the Namenda XR product. Forest states the reason for discontinuing the Namenda immediate-release tablets is to focus on the Namenda XR extended-release capsules. Forest will continue to market Namenda oral solution. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1082 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 142 Mannitol Inhalation Capsules August 07, 2014 Reason for the Shortage • • Pharmaxis states the reason for the shortage is manufacturing delay. There are no other manufacturers of mannitol inhalation capsules. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1096 Source link: http://www.ashp.org Haloperidol Lactate Injection August 07, 2014 Reason for the Shortage • • • • • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including haloperidol lactate injection. Mylan Institutional could not provide a reason for the shortage. Sagent has haloperidol lactate on shortage due to manufacturing delays. Teva has haloperidol lactate on shortage due to manufacturing delays. Mylan Institutional acquired haloperidol lactate injection from Pfizer on December 6, 2013. Patriot Pharmaceuticals states the reason for the shortage was increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=527 Source link: http://www.ashp.org Haloperidol Decanoate Injection August 07, 2014 Reason for the Shortage • Teva products are on shortage due to manufacturing delays. Copyright© PerformRx, LLC 2013 All Rights Reserved 143 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=526 Source link: http://www.ashp.org etomidate Injection August 07, 2014 Reason for the Shortage • • • • • • American Regent has etomidate injection on shortage due to manufacturing delays. Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Hospira has Amidate injection on shortage due to manufacturing delays. Mylan Institutional acquired etomidate injection from Pfizer on December 6, 2013. Mylan Institutional divested some presentations of etomidate injection to JHP Pharmaceuticals in April 2014. Mylan recalled 10 lots of etomidate injection with the Pfizer label in February 2014. The recall was due to the presence of particulate matter and missing lot numbers and expiration dates on the vials. Par Pharmaceuticals acquired JHP Pharmaceuticals in early 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=419 Source link: http://www.ashp.org Cytarabine Injection August 07, 2014 Reason for the Shortage • • • Fresenius Kabi (formerly APP) has cytarabine on shortage due to increased demand.1 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including cytarabine injection.2 Mylan Institutional acquired cytarabine injection from Pfizer on December 6, 2013.4,5 Mylan discontinued cytarabine 20 mg/mL 25 mL vials in 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=413 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 144 Cefpodoxime August 07, 2014 Reason for the Shortage • • • • Ranbaxy has an import ban on all solid medications including cefpodoxime. Aurobindo could not provide a reason for the shortage. Pfizer has discontinued Vantin. Sandoz could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=793 Source link: http://www.ashp.org Calcium Chloride Injection August 07, 2014 Reason for the Shortage • • American Regent has calcium chloride on shortage due to manufacturing delays. Hospira has calcium chloride on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=941 Source link: http://www.ashp.org Black Widow Antivenin (Latrodectus Mactans) August 07, 2014 Reason for the Shortage • • Merck has low inventory of Antivenin Latrodectus Mactans. Merck, working in combination with FDA, announced on July 3, 2014 that the expiration date for Antivenin lot H019984 was extended to January 3, 2015. The packaged Antivenin lot H019984 contains one vial of Antivenin lot 0672105, one vial of sterile diluent lot 0671078, and a 1 mL vial of horse serum for sensitivity testing. The expiration Copyright© PerformRx, LLC 2013 All Rights Reserved 145 dating for the sterile diluent has not been extended. Discard the sterile diluent and reconstitute the Antivenin vial with 2.5 mL of sterile water for injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=670 Source link: http://www.ashp.org Ampicillin Sulbactam August 07, 2014 Reason for the Shortage • • • • • • • AuroMedics Pharma launched new product in mid-June, 2012. Hospira states that ampicillin sulbactam vials are on back order due to manufacturing delay. Mylan Institutional discontinued ampicillin sulbactam injection in late 2013. Sagent has ampicillin sulbactam vials on allocation due to increased demand for the product. Pfizer and Sandoz cannot provide a reason for the shortage. WG Critical Care launched ampicillin sulbactam 1.5 gram vials in March 2014. West-Ward acquired several Baxter products in early 2011. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=805 Source link: http://www.ashp.org Aminocaproic Acid Injection August 07, 2014 Reason for the Shortage • American Regent has aminocaproic acid on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=789 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 146 Alprostadil Products August 07, 2014 Reason for the Shortage • • • • • • Bedford discontinued alprostadil in May, 2011 to concentrate on the manufacturing of other products. Teva’s product is on long-term back order due to manufacturing difficulties.2 Pfizer’s Caverject Impulse was on backorder while the product was reformulated. The company has discontinued Caverject injection 10 mcg lyophilized powder and 20 mcg/mL solution for injection.3 Actient has acquired several products from Schwarz (UCB) including Edex cartridges in 2010.4,5 Auxilium acquired Actient’s urology products including Edex cartridges in April 2013.6 Meda Pharmaceuticals has acquired Muse from Vivus.7,8 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=474 Source link: http://www.ashp.org Tenecteplase Injection August 08, 2014 Reason for the Shortage • Genentech states TNKase is on shortage due to increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1115 Source link: http://www.ashp.org Sterile Empty Vials August 08, 2014 Reason for the Shortage • Hospira states the shortage is due to manufacturing delays. Copyright© PerformRx, LLC 2013 All Rights Reserved 147 • • Fresenius Kabi (formerly APP) reduced production of sterile empty vials to permit increased production of drug products affected by critical shortages. Sterile empty vials may be available from medical supply distributors. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=890 Source link: http://www.ashp.org Lorazepam injectable presentations August 08, 2014 Reason for the Shortage • • • • • • Bedford discontinued lorazepam in May, 2011 to concentrate on the manufacturing of other products.1 West-Ward acquired Baxter’s lorazepam injection products in May, 2011. NDC numbers for the lorazepam and Ativan products were changed in April, 2012. West-Ward has Ativan on back order due to increase surplus of the lorazepam presentations.2 Hospira states lorazepam vials are on shortage due to increased demand and manufacturing delays. The 1 mL iSecure syringes were discontinued in September 2011.3 Akorn increased production to help meet demand.4 Amphastar had lorazepam 2 mg/mL vials on shortage due to increased demand.5 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=747 Source link: http://www.ashp.org Leucovorin Calcium Injection August 08, 2014 Reason for the Shortage • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired leucovorin calcium injection from Bedford in July 2014. West-Ward is not actively marketing amifostine injection at this time.1 Copyright© PerformRx, LLC 2013 All Rights Reserved 148 • • • Teva has leucovorin on shortage due to manufacturing delays. Teva imported leucovorin calcium (calcium folinate solution) 30 mL vials available; however, all product expired in July 2014. Teva will not be importing any additional calcium folinate solution.2 Fresenius Kabi (formerly APP) has leucovorin on shortage due to increase demand.3 Fusilev (levoleucovorin) and leucovorin oral tablets are not affected by the shortage.4-7 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=488 Source link: http://www.ashp.org Ketorolac Tromethamine Injection August 08, 2014 Reason for the Shortage • • • • • • • • American Regent discontinued all ketorolac injection presentations in 2010. Fresenius Kabi (formerly APP) states the shortage was due to manufacturing delays. Baxter could not provide a reason for the shortage. Cura filed for bankruptcy in 2010. Hospira has ketorolac on shortage due to manufacturing delays for quality improvement activities and increased demand for the product. Ben Venue has stopped production in its plant in Bedford, Ohio and closed in early 2014. West-Ward has ketorolac injection on shortage due to manufacturing delays. FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=593 Source link: http://www.ashp.org Hydroxyzine Injection August 08, 2014 Reason for the Shortage • • American Regent has hydroxyzine injection on shortage due to manufacturing delays. American Regent is the sole supplier of hydroxyzine injection Copyright© PerformRx, LLC 2013 All Rights Reserved 149 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=829 Source link: http://www.ashp.org Esmolol Injection August 08, 2014 Reason for the Shortage • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired esmolol injection from Bedford in July 2014. West-Ward is not actively marketing esmolol injection at this time. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=833 Source link: http://www.ashp.org Doxycycline Capsules and Tablets August 08, 2014 Reason for the Shortage • • • Actavis states the reason for the shortage is supply and demand.8 Teva discontinued their doxycycline presentations in May 2013. 6 Major discontinued most doxycycline presentations in February 2013. The company could not provide a reason for the discontinuation.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=977 Source link: http://www.ashp.org Dextrose 5% Injection Large Volume Bags August 08, 2014 Reason for the Shortage • • Baxter states the shortage is due to increased demand.1 BBraun had 5% dextrose on allocation due to increased demand.2 Copyright© PerformRx, LLC 2013 All Rights Reserved 150 • Hospira states the shortage is due to increased demand and manufacturing delays.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1081 Source link: http://www.ashp.org Dexrazoxane Injection August 08, 2014 Reason for the Shortage • • • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired dexrazoxane injection from Bedford in July 2014. West-Ward is not actively marketing dexrazoxane injection at this time. Biocodex USA acquired Totect from Apricus Pharmaceuticals in April 2013. Apricus Pharmaceuticals acquired Topotarget USA in late 2011. Topotarget worked with FDA to extend the expiration date of specific batch numbers of Totect to 36 months. Information regarding this extension and the batch numbers can be found in four Dear Healthcare Customer letters available online. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=415 Source link: http://www.ashp.org Dexmethylphenidate Hydrochloride August 08, 2014 Reason for the Shortage • Teva and Mylan cannot provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1079 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 151 Deferoxamine Mesylate Injection August 08, 2014 Reason for the Shortage • • • • • Fresenius Kabi states the shortage is due to increased demand. Hospira has deferoxamine on shortage due to manufacturing delays. Teva discontinued all deferoxamine presentations in 2013. Watson discontinued all deferoxamine presentations. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired deferoxamine injection from Bedford in July 2014. West-Ward is not actively marketing deferoxamine injection at this time. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1008 Source link: http://www.ashp.org Ciprofloxacin Injection August 08, 2014 Reason for the Shortage • Claris, Hospira and Sagent could not provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=944 Source link: http://www.ashp.org Buprenorphine Injection August 08, 2014 Reason for the Shortage • • • American Regent has buprenorphine injection on shortage due to manufacturing delays. Hospira had buprenorphine on shortage due to API constraints and increased demand. West-Ward Pharmaceutical’s parent company, Hikma Pharmaceuticals, acquired buprenorphine injection from Bedford in July 2014. West-Ward is not actively marketing buprenorphine injection at this time. Copyright© PerformRx, LLC 2013 All Rights Reserved 152 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=938 Source link: http://www.ashp.org Bupivacaine Injection August 08, 2014 Reason for the Shortage • • • Fresenius Kabi (formerly APP) has Sensorcaine on shortage due to increased demand for the product. Hospira has Marcaine and bupivacaine on shortage due to manufacturing delays. AuroMedics introduced bupivacaine injection in February 2014. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=864 Source link: http://www.ashp.org Bacitracin Topical Ointment August 08, 2014 Reason for the Shortage • Sandoz, Perrigo, and G&W Labs cannot provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=677 Source link: http://www.ashp.org Phenytoin Injection August 11, 2014 Reason for the Shortage • • West-Ward has phenytoin on allocation due to increased demand.1,2 Hospira has phenytoin ampules on shortage due to increased demand for the product. Hospira discontinued phenytoin Carpuject syringes in August 2013 for business reasons.3 Copyright© PerformRx, LLC 2013 All Rights Reserved 153 • X-Gen Pharmaceuticals had phenytoin on shortage due to manufacturing delays.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=740 Source link: http://www.ashp.org Norepinephrine Injection August 11, 2014 Reason for the Shortage • • • Ben Venue closed its plant in Bedford, Ohio in July 2014.1,2 Teva temporarily discontinued norepinephrine in June 2010.3 Hospira has Levophed on shortage due manufacturing delays.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=712 Source link: http://www.ashp.org Tuberculin Purified Protein Derivate for Intradermal Injection August 13, 2014 Reason for the Shortage • • Sanofi Pasteur states the shortage was due to production delays JHP states the shortage was due to increased demand for the product Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=973 Source link: http://www.ashp.org Trace Elements Injection August 13, 2014 Reason for the Shortage • American Regent has trace element injection on back order due to manufacturing delays.1,2 Copyright© PerformRx, LLC 2013 All Rights Reserved 154 • • American Regent is the sole supplier of FDA-approved combined trace elements. In cooperation with FDA, Fresenius Kabi USA is providing Addamel N (adult trace element injection) and Peditrace (pediatric trace element injection) to the US market to help alleviate the shortage. Addamel N and Peditrace are manufactured in an FDAapproved facility in Norway by Fresenius Kabi AG, the parent company of Fresenius Kabi, USA.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=785 Source link: http://www.ashp.org Tobramycin Injection August 13, 2014 Reason for the Shortage • • • • • • Teva has tobramycin solution for injection on shortage due to manufacturing delays. Hospira has tobramycin on shortage due to manufacturing delays. Fresenius Kabi has tobramycin solution for injection on shortage due to increased demand. Pfizer acquired tobramycin injection from Akorn in early-May, 2011. Pfizer divested tobramycin injection to Mylan Institutional on December 6, 2013. Mylan Institutional could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=701 Source link: http://www.ashp.org Orphenadrine Citrate Injection August 13, 2014 Reason for the Shortage • • Sagent has orphenadrine on shortage due to increased demand for the product. Ben Venue closed its plant in Bedford, Ohio in July 2014. Orphenadrine was manufactured by Ben Venue for Bedford. Copyright© PerformRx, LLC 2013 All Rights Reserved 155 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=884 Source link: http://www.ashp.org Octreotide Injection August 13, 2014 Reason for the Shortage • • • • • • • Fresenius Kabi (formerly APP) reports that the shortage is due to increased demand for the product. Sandoz discontinued octreotide injection in 2nd quarter 2013. Sagent has octreotide on shortage due to increased demand for the product. Teva has octreotide on shortage due to manufacturing delays. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired octreotide injection from Bedford in July 2014. West-Ward is actively marketing octreotide injection. Wockhardt has octreotide on back order due to an import ban. Sandostatin LAR presentations from Novartis are not affected by this shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=803 Source link: http://www.ashp.org Methylprednisolone Acetate Injection August 13, 2014 Reason for the Shortage • • Sandoz and Teva could not provide a reason for the shortage. Pfizer had Depo-Medrol injection on shortage due to manufacturing delay. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=923 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 156 Methotrexate Injection August 13, 2014 Reason for the Shortage • • • • • • Sandoz recalled two lots of methotrexate 40 mL preservative-free vials in May 2013 due to discover of particulate matter during routine quality control inspection.5 Mylan Institutional acquired methotrexate injection from Pfizer on December 6, 2013. 4, 7 Mylan Institutional divested three presentations of methotrexate injection to Intas (Accord Healthcare) in April 2014.4,9 Bioniche was acquired by Mylan Institutional in September, 2011.4,6 Teva discontinued methotrexate 4 mL vials in October 2013 due to business reasons. 8 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including methotrexate injection.10 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=26 Source link: http://www.ashp.org Mecasermin Injection August 13, 2014 Reason for the Shortage • • Ipsen Pharmaceuticals states the shortage is due to a manufacturing delay and raw material shortage. Ipsen is working with FDA to allow the release of Increlex lot #341203F. This lot was produced at an alternate manufacturing site that has not been approved by FDA. Please see the Dear Health Care Provider letter for additional information. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1058 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 157 Mannitol Injection August 13, 2014 Reason for the Shortage • • • • Hospira had mannitol injection on shortage due to manufacturing delays. Fresenius Kabi had mannitol injection on shortage due to increased demand for the product. American Regent has mannitol injection on shortage due to manufacturing delays. Baxter could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=863 Source link: http://www.ashp.org Liotrix Tablets August 13, 2014 Reason for the Shortage • Thyrolar tablets from Forest Laboratories are on back order due to manufacturing changes. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=24 Source link: http://www.ashp.org Diphtheria, Tetanus Toxoid, and Acellular Pertussis Vaccine (DTaP) August 13, 2014 Reason for the Shortage • • Sanofi Pasteur states the reason for the Daptacel shortage is manufacturing delay.1,2,3 Sanofi Pasteur discontinued Tripedia in 2011. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=922 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 158 Diphtheria, Tetanus Toxoid, and Acellular Pertussis and Inactivated Poliovirus and Haemophilus B Conjugate Vaccine (DTaP - IPV/Hib) August 13, 2014 Reason for the Shortage • Sanofi Pasteur states the reason for the shortage is manufacturing delay, which will reduce supplies below current demand.1,2,3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=973 Source link: http://www.ashp.org Digoxin Injection August 13, 2014 Reason for the Shortage • West-Ward states the shortage is due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=748 Source link: http://www.ashp.org Dextran Low Molecular Weight (Dextran 40), 10% Injection August 13, 2014 Reason for the Shortage • Hospira states the reason for the shortage is manufacturing delay. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1108 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 159 Cefuroxime Sodium Injection August 13, 2014 Reason for the Shortage • • • • • Sagent states manufacture of cefuroxime 1.5 gram was suspended in March, 2013. No further production is planned. Hospira discontinued cefuroxime 1.5 gram and 7.5 gram vials in January, 2013. Covis launched the new NDC numbers in August 2013. BBraun discontinued their cefuroxime solution in December 2013. Fresenius Kabi discontinued manufacturing cefuroxime in 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=990 Source link: http://www.ashp.org Oxycodone/Acetaminophen Oral Solution August 14, 2014 Reason for the Shortage • • • • Roxane states that the reason for the shortage is that they are validating a new source for raw materials. Roxane discontinued oxycodone/acetaminophen 5 mL unit-dose cups in July 2014. Oxycodone/acetaminophen oral solution is not available from other manufacturers or in other concentrations. This shortage does not affect single-ingredient oxycodone solutions or oxycodone/acetaminophen solid oral dosage forms Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1117 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 160 Ondansetron Injection August 14, 2014 Reason for the Shortage Ondansetron 2 mg/mL vials • • • • • • • • • • AuroMedics did not provide a reason for the shortage. Caraco temporarily discontinued ondansetron injection. West-Ward acquired Baxter’s ondansetron vials for injection. West-Ward discontinued ondansetron 2 mg/mL vials in packages of 5 in Spring, 2012. BD launched ondansetron 2 mg/mL prefilled syringes in September 2013. Ben Venue stopped production in its plant in Bedford, Ohio and closed in July, 2014. Hospira has ondansetron on shortage due to manufacturing delays. Mylan Institutional acquired ondansetron injection from Pfizer on December 7, 2013. Mylan Institutional temporarily discontinued ondansetron 2 mg/mL injectable products in February 2014. Teva is temporarily discontinuing ondansetron 20 mL injection. West-Ward had ondansetron on back order due to increased demand. Wockhardt has ondansetron injection on shortage due to an FDA import alert. Ondansetron 32 mg/50 mL premixed bags • • • • • • • • All presentations of ondansetron 32 mg/50 mL premixed bags have been discontinued. Single-dose IV ondansetron 32 mg is no longer recommended due to an increased potential for QT prolongation and has been removed from the Zofran product labeling. The maximum dose for chemotherapy-induced nausea should not exceed 16 mg. FDA is working with manufacturers to voluntarily recall all ondansetron 32 mg premixed bags from the market by early 2013. Oral ondansetron dosing is not affected by the new recommendations, including the 24 mg oral dose for chemotherapy-induced nausea and vomiting. Baxter has discontinued and recalled their ondansetron premixed bags. Bedford discontinued their ondansetron premixed bags in December, 2012. Hospira discontinued their ondansetron premixed bags in December, 2012. Product has not been available on the market for several years. Claris recalled all lots of their ondansetron premixed bags in mid-2010. Claris discontinued their ondansetron premixed bags in June 2013. Pfizer discontinued their ondansetron premixed bags in January, 2012. Copyright© PerformRx, LLC 2013 All Rights Reserved 161 • • Teva discontinued their ondansetron premixed bags in late-November, 2012. Product has not shipped since early 2010. West-Ward has discontinued their ondansetron premixed bags. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1040 Source link: http://www.ashp.org Nitroglycerin Injection August 14, 2014 Reason for the Shortage • • • • • American Regent has recently upgraded their manufacturing plant. Product will become available in stages as production resumes.1 Hospira states the shortage is due to manufacturing delays.2 Hospira discontinued nitroglycerin in Dextrose 5%, 40 mg/100 mL, 500 mL glass bottles (NDC 00409-1484-03) in 2010.2 Baxter had nitroglycerin premixes on shortage due to a raw material supply issue.3 In cooperation with FDA, Arbor Pharmaceuticals is importing glyceryl trinitrate (Nitronal) injection to the US market to help alleviate the national shortage. This glyceryl trinitrate is manufactured in an FDA-approved facility in Germany by Pohl Boskamp. Glyceryl trinitrate is another name for nitroglycerin.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=786 Source link: http://www.ashp.org Milrinone Injection August 14, 2014 Reason for the Shortage • • • • Fresenius Kabi (formerly APP) states the reason for the shortage is increased demand for the product. West-Ward acquired Baxter’s milrinone injection vials in May 2011. West-Ward states the shortage is due to manufacturing delays. Baxter had milrinone premixed bags on shortage due to increased demand. Copyright© PerformRx, LLC 2013 All Rights Reserved 162 • • • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Apotex, Bioniche, and Teva discontinued milrinone 1 mg/mL vials. Sanofi-Aventis discontinued Primacor injection Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=741 Source link: http://www.ashp.org Tiopronin Tablets August 15, 2014 Reason for the Shortage • • Mission Pharmacal had Thiola on shortage due to raw materials being discontinued. Thiola tablets are supplied by Mission Pharmacal and distributed by Retrophin. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1067 Source link: http://www.ashp.org Tamsulosin Hydrochloride Capsules August 15, 2014 Reason for the Shortage • • • • • Boehringer Ingelheim cannot provide a reason for the shortage. Actavis and Zydus state the reason for the shortage is increased demand. Aurobindo, Caraco, and Mylan cannot provide a reason for the shortage. Teva discontinued tamsulosin 0.4 mg capsules in April 2014. Par discontinued tamsulosin 0.4 mg capsules. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1112 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 163 Sodium Acetate Injection August 15, 2014 Reason for the Shortage • • • • • American Regent has sodium acetate on shortage due to manufacturing delays. American Regent has discontinued sodium acetate 2 mEq/mL 100 mL vials. Fresenius Kabi has sodium acetate on shortage due to increased demand. Hospira had sodium acetate on shortage due to manufacturing delays. Baxter discontinued sodium acetate in June, 2008. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=762 Source link: http://www.ashp.org Potassium Phosphate Injection August 15, 2014 Reason for the Shortage • • • • • American Regent has potassium phosphate injection on back order due to manufacturing delays.1,2 American Regent has issued a statement that all lots of potassium phosphate may contain glass particles and filters must be used. Do not use if there are visible glass particles and filter all other product.3,4 Hospira has potassium phosphate 15 mL vials on shortage due to increased demand.5 In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG.6 Fresenius Kabi, USA (formerly APP) launched potassium phosphate injection in November 2013.7 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=709 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 164 Phytonadione (Vitamin K) Injection August 15, 2014 Reason for the Shortage • • • Amphastar has vitamin K injection on shortage due to increased demand for the product. Hospira has vitamin K injection on shortage due to increased demand for the product. Oral vitamin K is not affected by this shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=852 Source link: http://www.ashp.org Phenylephrine 2.5% and 10% Ophthalmic Solution August 15, 2014 Reason for the Shortage • • • • • Akorn stopped manufacturing phenylephrine ophthalmic solution in April 2014 and stopped distributing product on June 30, 2014.1 Alcon discontinued phenylephrine 2.5% ophthalmic solution with the Sandoz label in April 2014.2 Alcon discontinued Mydfrin 2.5% ophthalmic solution in 2014. 2 Hub discontinued phenylephrine 2.5% and 10% ophthalmic solution in 2013.3 Phenylephrine 2.5% and 10% from Paragon BioTeck is the only FDA-approved phenylephrine ophthalmic product. Paragon BioTeck supplies phenylephrine ophthalmic solution 2.5% and 10% and this is distributed by Bausch & Lomb (a division of Valeant).4,5 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1105 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 165 Pantoprazole Tablets August 15, 2014 Reason for the Shortage • • • Actavis, Aurobindo, Mylan, Teva, and Torrent could not provide a reason for the shortage. Kremers Urban state the shortage is due to increased demand. FDA imposed an import ban in mid-2013 on several Wockhardt products including pantoprazole. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=979 Source link: http://www.ashp.org Methylphenidate Hydrochloride August 15, 2014 Reason for the Shortage • • • • • Mallinckrodt states the shortage was due to delay in obtaining raw materials. The company has stopped using the trade name Methylin and all products are now marketed as methylphenidate immediate-release or extended-release tablets with new NDC numbers. Sandoz states that the shortage is due to delay in obtaining raw materials. Teva introduced generic methylphenidate extended release capsules (CD) in lateSeptember 2012, and these capsules are AB-rated to Metadate CD capsules. UCB states methylphenidate IR tablets were on shortage due to supply and demand. Actavis (formerly Watson) says the methylphenidate IR tablets were on shortage due to supply constraints. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=752 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 166 Indomethacin Injection August 15, 2014 Reason for the Shortage • • • • Indomethacin for injection is on nationwide back order due to manufacturing issues.1,2 Lundbeck sold several products to Recordati in January 2013 including Indocin IV and NeoProfen IV. Recordati is not currently manufacturing Indocin IV but NeoProfen is available.3 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired indomethacin injection from Bedford in July 2014. West-Ward is not actively marketing indomethacin injection at this time.2 Fresenius Kabi (formerly APP) had indomethacin injection on shortage due to increase demand for the product.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=596 Source link: http://www.ashp.org Fluorouracil Injection August 15, 2014 Reason for the Shortage • • • • Fresenius Kabi (formerly APP) states fluorouracil is on allocation to prevent excessive purchases.1 Teva has fluorouracil on back order due to manufacturing issues.2 Mylan Institutional temporarily discontinued their fluorouracil injection in May 2013.3 Mylan Institutional acquired fluorouracil injection from Pfizer on December 6, 2013. 3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=798 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 167 Erythromycin Lactobionate Injection August 15, 2014 Reason for the Shortage • • Hospira has Erythrocin 500 mg vials on shortage due to manufacturing delays.1 Hospira is the sole supplier of erythromycin lactobionate. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=546 Source link: http://www.ashp.org Doxapram Injection August 15, 2014 Reason for the Shortage • • Ben Venue closed its plant in Bedford, Ohio in July 2014. West-Ward had Dopram on shortage due to manufacturing delays Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=877 Source link: http://www.ashp.org Dopamine Injection August 15, 2014 Reason for the Shortage • • • • B Braun discontinued their dopamine premix in November 2012 due to raw material supply issues. Hospira states the shortage is due to manufacturing delays. American Regent has recently upgraded their manufacturing plant. Product will become available in stages as production resumes. Baxter had dopamine on allocation due to increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=88 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 168 Dexmedetomidine August 15, 2014 Reason for the Shortage • • Hospira states the reason for the shortage is manufacturing delay. There are no other manufacturers of dexmedetomidine injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1092 Source link: http://www.ashp.org Dacarbazine Injection August 15, 2014 Reason for the Shortage • • Teva has dacarbazine on back order due to manufacturing delays.1 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired dacarbazine injection from Bedford in July 2014. West-Ward is not actively marketing dacarbazine injection at this time.5 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=949 Source link: http://www.ashp.org Clonidine Injection August 15, 2014 Reason for the Shortage • • • • American Regent has clonidine injection temporarily unavailable due to manufacturing delay. X-Gen states the reason for the shortage is increased demand. Mylan Institutional could not provide a reason for the shortage. West-Ward states the reason for the shortage is manufacturing delay. Copyright© PerformRx, LLC 2013 All Rights Reserved 169 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1111 Source link: http://www.ashp.org Clindamycin Injection August 15, 2014 Reason for the Shortage • • • • • Pfizer states the Cleocin Add-Vantage vials are on shortage due to manufacturing delays. Hospira has clindamycin injection on shortage due to manufacturing delays. Akorn launched clindamycin injection in June 2013. Sandoz had clindamycin injection on shortage due to increased demand. Sagent has clindamycin injection on shortage due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1029 Source link: http://www.ashp.org Ceftazidime Injection August 15, 2014 Reason for the Shortage • • • • • • Pfizer discontinued all of its ceftazidime injection products in late-November, 2011. West-Ward discontinued all of its ceftazidime injection products in January 2012. Hospira has ceftazidime on shortage due to manufacturing delays. Covis purchased all rights to Fortaz from GlaxoSmithKline. Covis began changing NDC numbers in December 2012. Sagent had ceftazidime injection on shortage due to increased demand for the product. WG Critical Care launched ceftazidime 1 gram vials in July 2013 and product is available at wholesalers. Ceftazidime 2 gram and 6 gram presentations were launched in August 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=869 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 170 Butorphanol Injection August 15, 2014 Reason for the Shortage • • • • • Apotex discontinued butorphanol injection in 2008. Ben Venue closed its plant in Bedford, Ohio in July 2014. Hospira states the shortage was due to manufacturing delays. West-Ward discontinued butorphanol injection in early 2012. Sandoz discontinued Stadol injection in 2010. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=939 Source link: http://www.ashp.org Bupropion Hydrochloride 24 hour ER Tablets August 15, 2014 Reason for the Shortage • • Global and Par state the reason for the shortage is increased demand for product. Mylan cannot provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1106 Source link: http://www.ashp.org Water-Miscible Oral Multiple Vitamins August 18, 2014 Reason for the Shortage • • • • • Source CF could not provide a reason for the shortage. Axcan Pharma discontinued ADEKs chewable tablets in May 2011. Macoven discontinued AKEDamins in early-2014. Standard multivitamins are not affected by this shortage. Libertas launched softgel capsules in early-July 2014. Copyright© PerformRx, LLC 2013 All Rights Reserved 171 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=991 Source link: http://www.ashp.org Sterile Water Irrigation August 18, 2014 Reason for the Shortage • • • Baxter has sterile water for irrigation on shortage due manufacturing delays.1 BBraun only has product available for existing customers.2 Hospira only has product available for existing customers.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1120 Source link: http://www.ashp.org Sodium Chloride 0.9% Irrigation August 18, 2014 Reason for the Shortage • • • Baxter has 0.9% sodium chloride irrigation on shortage due manufacturing delays. 1 BBraun only has product available for existing customers.2 Hospira only has product available for existing customers.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1118 Source link: http://www.ashp.org Methylprednisolone Sodium Succinate Injection August 18, 2014 Reason for the Shortage • Hospira discontinued all methylprednisolone sodium succinate products in January 2013 due to raw material issues.1 Copyright© PerformRx, LLC 2013 All Rights Reserved 172 • • • Bedford discontinued methylprednisolone in May, 2011 to concentrate on the manufacturing of other products.2 Pfizer had Solu-Medrol on shortage due to manufacturing delays.3 Fresenius Kabi (formerly APP) has methylprednisolone sodium succinate on shortage due to priority of other medications.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1077 Source link: http://www.ashp.org Lactated Ringer's Irrigation August 18, 2014 Reason for the Shortage • • • Baxter has lactated ringer’s on shortage due manufacturing delays.1 BBraun only has product available for existing customers.2 Hospira only has product available for existing customers.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1119 Source link: http://www.ashp.org Isoniazid Tablets August 18, 2014 Reason for the Shortage • • Versapharm could not provide a reason for the shortage. West-Ward discontinued isoniazid tablets in late-November 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=985 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 173 Furosemide Injection August 18, 2014 Reason for the Shortage • • • • Fresenius Kabi (formerly APP) has furosemide injection on shortage due to increased demand for the product.1 American Regent has furosemide injection on shortage due to manufacturing delays.3 Hospira states the shortage is due to manufacturing delays.5 Wockhardt has discontinued all furosemide injection presentations.6 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=636 Source link: http://www.ashp.org Doxycycline Hyclate Injection August 18, 2014 Reason for the Shortage • • Mylan Institutional states the shortage is due to supplier availability. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including doxycycline injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=431 Source link: http://www.ashp.org Bumetanide Injection August 18, 2014 Reason for the Shortage • • • • Ben Venue closed its plant in Bedford, Ohio in July 2014. Baxter discontinued bumetanide 0.25 mg/mL 2 mL vial in early-2011. West-Ward acquired several Baxter products including bumetanide in mid-2011. Bumetanide was on shortage because demand exceeded supply. Hospira had bumetanide on shortage due to manufacturing delays. Copyright© PerformRx, LLC 2013 All Rights Reserved 174 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=674 Source link: http://www.ashp.org Acetylcysteine Inhalation Solution August 18, 2014 Reason for the Shortage • • • • American Regent has acetylcysteine inhalation on shortage due to manufacturing delays. Roxane Labs discontinued acetylcysteine inhalation solution in April 2014. The product had previously been on shortage due to manufacturing delays. Hospira has acetylcysteine inhalation solution on shortage due to manufacturing delay. Fresenius Kabi (formerly APP) states the reason for the shortage was increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=932 Source link: http://www.ashp.org Piperacillin Tazobactam Injection August 19, 2014 Reason for the Shortage • • • Hospira has piperacillin/tazobactam on shortage due to manufacturing delays. Pfizer has Zosyn on shortage due to manufacturing delays. WG Critical Care states the reason for the shortage was increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1075 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 175 Olanzapine Injection August 19, 2014 Reason for the Shortage • • American Regent states the reason for the shortage is manufacturing delay. Sandoz states the reason for the shortage is increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1093 Source link: http://www.ashp.org Fludarabine Injection August 19, 2014 Reason for the Shortage • • • • • • • • Fresenius Kabi, USA (formerly APP) had fludarabine lyophilized powder for injection on shortage due to focus on supplying solution for injection.1 Fresenius Kabi, USA had fludarabine solution for injection on shortage due to increased demand.1 Teva had fludarabine on shortage due to manufacturing delays.2 Sagent had fludarabine on shortage due to manufacturing delays.3 Hospira had fludarabine on shortage due to manufacturing delays.4,5 Sandoz had fludarabine on back order due to manufacturing delays.6 Mylan Institutional temporarily discontinued fludarabine injection in late-April 2013.7 Genzyme discontinued Fludara in July, 2012.8 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=648 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 176 Daunorubicin Hydrochloride Injection August 19, 2014 Reason for the Shortage • • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired daunorubicin injection and Cerubidine injection from Bedford in July 2014. West-Ward is not actively marketing daunorubicin injection or Cerubidine injection at this time.1 Teva states daunorubicin was on back order due to manufacturing delays.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1007 Source link: http://www.ashp.org Carboplatin Solution for Injection August 19, 2014 Reason for the Shortage • • • • • Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of other products.1 Teva has carboplatin injection on shortage due to manufacturing delays.2,3,4 Fresenius Kabi has carboplatin on shortage due to increased demand for the product.5 Sandoz has carboplatin on shortage due to manufacturing delays.6 Sagent launched carboplatin in November 2013.7 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1005 Source link: http://www.ashp.org Caffeine Citrate Injection and Oral Solution August 19, 2014 Reason for the Shortage • • • American Regent has caffeine citrate on shortage due to manufacturing delays. Paddock discontinued caffeine citrate injection and oral solution in May 2014. Sagent states the reason for the shortage is increased demand. Copyright© PerformRx, LLC 2013 All Rights Reserved 177 • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired Cafcit from Bedford in July 2014. West-Ward is actively marketing Cafcit injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=862 Source link: http://www.ashp.org Acyclovir Suspension August 19, 2014 Reason for the Shortage • • Hi-Tech discontinued acyclovir suspension in April 2014. Actavis could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1018 Source link: http://www.ashp.org Rocuronium Injection August 20, 2014 Reason for the Shortage • • • • • • Merck discontinued Zemuron 10 mL multidose vials in the 3rd Quarter of 2013. Merck discontinued Zemuron 5 mL vials in June 2014.1 Mylan Institutional states the reason for the shortage was increased demand.2,3 Hospira had rocuronium on shortage due to manufacturing delays.4 Teva has rocuronium on shortage due to manufacturing delays.5 Fresenius Kabi and Sagent cited increased demand as the reason for this shortage.6,8 The Medicines Company launched rocuronium in early 2014.9 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=434 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 178 Paclitaxel Injection August 20, 2014 Reason for the Shortage • • • • • • • • Fresenius Kabi (formerly APP) has paclitaxel on shortage due to increase demand for the product.1 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired paclitaxel injection from Bedford in July 2014. West-Ward is not actively marketing paclitaxel.2,3 Teva has paclitaxel on shortage due to manufacturing delays.4 Sandoz has paclitaxel on back order due to a raw material shortage.5 Hospira had paclitaxel on shortage due to increased demand.6,7 Sagent has paclitaxel on shortage due to increased demand.8 Pfizer launched paclitaxel 100 mg and 300 mg vials in March, 2012 and launched the 30 mg vials in April, 2012.9 Mylan Institutional acquired paclitaxel injection from Pfizer on December 7, 2013.9,10 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=790 Source link: http://www.ashp.org Oxacillin Sodium Injection August 20, 2014 Reason for the Shortage • • • Auromedics states the reason for the shortage is increased demand. Sagent states the reason for the shortage is manufacturing delay. Sandoz states the reason for the shortage is difficulty obtaining the active pharmaceutical ingredient. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1121 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 179 Nimodipine Capsules August 20, 2014 Reason for the Shortage • • • Caraco cannot provide a reason for the shortage. Heritage cannot provide a reason for the shortage. Teva discontinued nimodipine capsules in early-March, 2013. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=970 Source link: http://www.ashp.org Midazolam Injections August 20, 2014 Reason for the Shortage • • • • • • • • • West-Ward acquired Baxter’s midazolam injection products in May, 2011.1 Ben Venue stopped production in its plant in Bedford, Ohio and closed in 2014.2 Hospira has midazolam on shortage due to manufacturing delays and demand exceeding supply due to current market conditions.3 Hospira discontinued midazolam 5 mg/mL 1 mL iSecure syringes in July 2011.3 Fresenius Kabi (formerly APP) had midazolam on shortage due to increased demand.4 Due to low demand, Akorn is focusing on other medications that are in greater need of supply.5 Caraco discontinued two midazolam presentations in 2014.7 FDA imposed an import ban in mid-2013 on several Wockhardt products including midazolam injection.8 Medicines Company launched midazolam injection in early 2014.9 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=858 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 180 Fluorescein sodium injection August 20, 2014 Reason for the Shortage • • Altaire Pharmaceuticals temporarily discontinued fluorescein and fluorescein lite products. Altaire Pharmaceuticals could not provide a reason for the temporary discontinuation. Alcon could not provide a reason for the shortage. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1104 Source link: http://www.ashp.org Famotidine Injection August 20, 2014 Reason for the Shortage • • • • • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.1 West-Ward states the shortage is due to manufacturing delays.2 Oral famotidine products are not affected by this shortage. Pfizer launched famotidine injections in March, 2012.3 Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=810 Source link: http://www.ashp.org Digoxin Injection August 20, 2014 Reason for the Shortage • West-Ward states the shortage is due to manufacturing delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=748 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 181 Ephedrine Injection August 20, 2014 Reason for the Shortage • Hospira discontinued ephedrine in March, 2011. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=351 Source link: http://www.ashp.org Dimercaprol Injection August 20, 2014 Reason for the Shortage • Akorn could not provide a reason for the shortage Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1086 Source link: http://www.ashp.org Diltiazem Injection August 20, 2014 Reason for the Shortage • • • • • • Ben Venue stopped product in its plant in Bedford, Ohio and closed in July 2014. Hospira states the reasons for the shortage are manufacturing delays and increases in demand. West-Ward had diltiazem injection on shortage due to manufacturing delays caused by increased demand due to current market conditions. Akorn states the reason for the shortage is increased demand due to market conditions. Teva discontinued all diltiazem presentations in March, 2011. Biovail discontinued Cardizem Lyo-Ject in 2007 due to business reasons. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=217 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 182 Acyclovir Injection August 20, 2014 Reason for the Shortage • • • Fresenius Kabi (formerly APP) is not manufacturing acyclovir lyophilized powder to concentrate on supplying the solution for injection.1 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.2 AuroMedics introduced acyclovir injection in February 2014.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=467 Source link: http://www.ashp.org Vancomycin Hydrochloride Injection August 21, 2014 Reason for the Shortage • • • • • • • • Hospira has vancomycin on shortage due to increased demand.1 Fresenius Kabi (formerly APP) has vancomycin injection on shortage due to increased demand.2 Sagent has vancomycin on shortage due to increased demand.8 Akorn has sold their vancomycin products to Pfizer and stopped distributing on April 29, 2011.3 Mylan Institutional acquired vancomycin injection from Pfizer on December 6, 2013.4, 6 Mylan Institutional (formerly Bioniche) has acquired multiple products from Generamedix, including vancomycin hydrochloride.4,5 Mylan Institutional discontinued two vancomycin presentations in September 2013.4 Pfizer acquired multiple products from Akorn, including vancomycin hydrochloride in early-May, 2011.3,6 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=132 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 183 Sodium Chloride 0.45% Injection Bags August 21, 2014 Reason for the Shortage • • • Baxter has 0.45% sodium chloride on shortage due to increased demand.1 BBraun had 0.45% sodium chloride on allocation due to increased demand. 2 Hospira cited increased demand as the reason for the shortage.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1083 Source link: http://www.ashp.org Prochlorperazine Edisylate Injection August 21, 2014 Reason for the Shortage • • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.1 Heritage launched prochlorperazine 5 mg/mL 2 mL vials in January 2014.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1063 Source link: http://www.ashp.org Pancuronium Injection August 21, 2014 Reason for the Shortage • • Teva discontinued their pancuronium presentations in May, 2010. 1 Hospira’s product is on back order due to manufacturing delays and retesting of raw material. Hospira is the only manufacturer of pancuronium.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=851 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 184 Fosphenytoin Injection August 21, 2014 Reason for the Shortage • • • • • • • • Akorn discontinued fosphenytoin injection in 2011.1 Fresenius Kabi recalled numerous lots of fosphenytoin due to particulate matter potentially from glass delamination and consistent with glass particulates observed in samples. Fresenius Kabi has a letter discussing the lot numbers and what to do with affected product.2 American Regent discontinued fosphenytoin injection in late-2010.3 Bedford discontinued fosphenytoin in May, 2011 to concentrate on the manufacturing of other products.4 Hospira states the shortage is due to manufacturing delays.5,6 Pfizer discontinued the Cerebyx 500 mg presentation in September, 2009 and the 1 gram presentation in early-February, 2010.7 Pfizer launched Cerebyx 2 mL and 10 mL vials in October 2013.7 Teva, Apotex, Baxter, GeneraMedix, and Wockhardt have discontinued their fosphenytoin presentations.8-12 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=127 Source link: http://www.ashp.org Cyclosporine Injection August 21, 2014 Reason for the Shortage • • Perrigo acquired Paddock Laboratories in July 2011. Perrigo discontinued cyclosporine injection in late-November, 2011. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired cyclosporine injection from Bedford in July 2014. West-Ward is not actively marketing cyclosporine injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=948 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 185 Cisplatin Injection August 21, 2014 Reason for the Shortage • • • • Fresenius states the shortage was due to increased demand and manufacturing delays.1 Mylan Institutional has cisplatin only available with short-dating.2 Teva is allocating cisplatin to prevent stockpiling.3 WG Critical Care is allocating product due to increased demand.4 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=57 Source link: http://www.ashp.org Ceftriaxone Sodium Injection August 21, 2014 Reason for the Shortage • • • • • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Fresenius Kabi states the reason for the shortage is increased demand. Hospira states the reason for the shortage is manufacturing delay. Sandoz cannot provide a reason for the shortage. WG Critical Care states the reason for the shortage is increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1101 Source link: http://www.ashp.org Cefotetan Disodium Injection August 21, 2014 Reason for the Shortage • Fresenius Kabi states the reason for the shortage is manufacturing delay. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1097 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 186 Cefazolin Injection August 21, 2014 Reason for the Shortage • • • • Fresenius Kabi, BBraun, West-Ward, and WG Critical Care have cefazolin on shortage due to increased demand. Apotex and Sandoz have cefazolin on shortage due to manufacturing delays. Hospira has cefazolin on shortage due to manufacturing delays and increased demand. Sagent has cefazolin on shortage due to increased demand and shipping delays. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=987 Source link: http://www.ashp.org Bleomycin Injection August 21, 2014 Reason for the Shortage • • • Fresenius Kabi state bleomycin is on shortage due to increased demand.1 Hospira states bleomycin is in short supply due to manufacturing delays.2 Teva states bleomycin is on shortage due to increased demand.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=276 Source link: http://www.ashp.org Amiodarone Hydrochloride Injection August 21, 2014 Reason for the Shortage • • • Hospira had amiodarone injection on shortage due to manufacturing delays. Fresenius Kabi has amiodarone injection on shortage due to increased demand. West-Ward stated the reason for the shortage is demand exceeding supply due to current market conditions. Copyright© PerformRx, LLC 2013 All Rights Reserved 187 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=358 Source link: http://www.ashp.org Tranexamic Acid Injection August 22, 2014 Reason for the Shortage • • Fresenius Kabi (formerly APP) has tranexamic acid injection on shortage due to increased demand for the product. X-Gen has tranexamic acid on shortage due to increased demand. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1049 Source link: http://www.ashp.org Sumatriptan Succinate Injection August 22, 2014 Reason for the Shortage • • • • • Sagent states the reason for the shortage is increased demand. Par Sterile Products (formerly JHP) could not provide a reason for the shortage. GlaxoSmithKline could not provide a reason for the shortage. Pfizer has had Alsuma on shortage since September 2013 due to manufacturing issues. Teva has temporarily suspended the production of sumatriptan injection. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1085 Source link: http://www.ashp.org Sufentanil Injection August 22, 2014 Reason for the Shortage • West-Ward has sufentanil on shortage due to manufacturing delays.1 Copyright© PerformRx, LLC 2013 All Rights Reserved 188 • • Hospira has sufentanil on shortage due to manufacturing delays.2 Akorn could not provide a reason for the shortge.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=823 Source link: http://www.ashp.org BCG Vaccine Live Intravesical August 22, 2014 Reason for the Shortage • • • Sanofi Pasteur states the reason for the shortage is manufacturing delay.1 Merck states the reason for the shortage is manufacturing delay.2 Merck states Tice BCG vaccine percutaneous for tuberculosis (Merck, NDC 00052-060302) is also affected because this product is manufactured at the same facility.2 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=915 Source link: http://www.ashp.org Sincalide Injection August 25, 2014 Reason for the Shortage • • Bracco Diagnostics has Kinevac on shortage due to manufacturing delays. There are no approved alternatives to Kinevac for the labeled indications. Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1032 Source link: http://www.ashp.org Papaverine Injection August 25, 2014 Reason for the Shortage Copyright© PerformRx, LLC 2013 All Rights Reserved 189 • • • Bedford and Sandoz have discontinued their papaverine presentations.1,2 American Regent has papaverine on shortage due to manufacturing delays.3 American Regent is the sole supplier of papaverine.3 Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=781 Source link: http://www.ashp.org Copyright© PerformRx, LLC 2013 All Rights Reserved 190 NEW DRUGS COMING TO MARKET PRODUCT MFR ROUTE INDICATION Dulaglutide (Trulicity) Inhaled Technosphere® Insulin (Afrezza) Lilly INJ (SC) Type II diabetes MannKind/Sanofi Inhaled insulin Type 1 & 2 diabetes Empagliflozin and linagliptin Boehringer Ingelheim/ Eli Lilly PO Type II diabetes Toujeo Sanofi INJ (SC) Type 1 & 2 diabetes Oritavancin (Orbactiv) The Medicines Company INJ (IV) Gram positive infections Abacavir/ dolutegravir/ lamivudine ViiV healthcare PO HIV Ledipasvir/ sofosbuvir Gilead PO Hepatitis C Daclatasvir Bristol-Myers Squibb PO Hepatitis C Copyright© PerformRx, LLC 2013 All Rights Reserved PHARMACOLOGY GLP-1 receptor agonist (once weekly) Palm-sized inhaler with single use cartridges Sodium-glucose cotransporter-2 (SGLT2) inhibitor and DPP-4 inhibitor Long acting U300 basal insulin Lipoglycopeptide that inhibits cell wall synthesis Single tab combining integrase inhibitor, replication inhibitor, nucleoside reverse transcriptase inhibitor Fixed dose combination of NS5A protein inhibitor, nucleotide NS5B inhibitor NS5A protein inhibitor MARKET RELEASE NDA filed 9/18/2013 FDA approved 627-2014; Launch expected early 2015; Sanofi signed marketing agreement 8/14 NDA filed 4/14 NDA filed 7/14 FDA approved 8/7/14; Qualified Infectious Disease Product (QIDP) designation NDA filed 10/22/2013; FDA action date 10/14 NDA filed 2/14; Breakthrough therapy designation granted 8/13; priority review; FDA action date 10/10/14 NDA filed 4/14; triple therapy break- 191 PRODUCT MFR ROUTE INDICATION PHARMACOLOGY Asunaprevir Bristol-Myers Squibb PO Hepatitis C NS3 protease inhibitor Elvitegravir Gilead PO HIV Integrase inhibitor ABT-450 (plus ritonavir) AbbVie PO Hepatitis C Hepatitis C virus (HCV) NS3/4A protease inhibitor (given with ritonavir as booster) Ombitasvir (ABT-267) AbbVie PO Hepatitis C Hepatitis C virus (HCV) NS5A inhibitor Copyright© PerformRx, LLC 2013 All Rights Reserved MARKET RELEASE through therapy designation (with asunaprevir & BMS 791325) for chronic Hepatitis C NDA filed 4/14; triple therapy breakthrough therapy designation (with daclatasvir & BMS 791325) for chronic hepatitis C NDA filed 6/12. FDA complete response letter 4/27/13. NDA re-submitted 4/14. FDA action date 10/4/14 All oral triple therapy (with ABT-267 and ABT-333) receives FDA breakthrough therapy designation 5/13’ NDA filed 4/22/14 All oral triple therapy (with ABT-450 and ABT-333) received FDA breakthrough 192 PRODUCT Dasabuvir (ABT333) MFR AbbVie ROUTE PO PO INDICATION Hepatitis C PHARMACOLOGY Hepatitis C virus (HCV) non-nucleoside polymerase inhibitor Protease inhibitor and pharmacokinetic enhancer Omega-3 fatty acid Darunavir and cobicistat Gilead Epanova Omthera PO Hypertriglyceridemia Ceftolozane/ tazobactam Cubist INJ (IV) Complicated Urinary Tract Infections (cUTI) and complicated IntraAbdominal Infections (cIAI) Cephalosporin/betalactase inhibitor combination Peramavir BioCryst INJ (IV) Influenza Isavuconazole Basilea PO, IV Treatment of systemic and invasive Candida and Aspergillus infections Cyclopentane compound that selectively inhibits the influenza A and B neuraminidase enzyme Binds and inhibits ergosterol synthesis by inhibiting CYP450dependant 14-alpha sterol demethylase HIV Copyright© PerformRx, LLC 2013 All Rights Reserved MARKET RELEASE therapy designation 5/13; NDA filed 4/22/14 All oral triple therapy (with ABT-267 and ABT-450) receives FDA breakthrough therapy designation 5/13; NDA filed 4/22/14 NDA filed 4/14 FDA approved 5/6/14; Amarin filed lawsuit that may delay launch NDA filed 423-2014; FDA fast track and Qualified Infectious Disease Product (QIDP) designation; priority review; FDA action date 12-21-2014 NDA filed 122013; FDA action date 12-23-2014 Orphan drug status; Qualified Infectious Disease 193 PRODUCT MFR ROUTE INDICATION PHARMACOLOGY Pembrolizumab (MK-3475, Lambrolizumab) Merck INJ (IV) Melanoma; NSCLC Specifically targets the “programmed death” 1 (PD-1) receptor Olaparib AstraZeneca PO Breast Cancer; Ovarian Cancer Poly-ADP-ribose polymerase (PARP) enzyme inhibitor Panobinostat (Faridak; LBH589) Novartis PO Cutaneous T-cell Lymphoma, CML, MDS Brexpiprazole Otsuka PO Naloxegol (Movantik) Nektar/AstraZeneca PO Depression, ADHD, schizophrenia Opioid-induced constipation Secukinumab (AIN-457) Novartis INJ (SC and IV) Novel and highly potent histone deacetylase (HDAC) inhibitor that induces cell death of tumor cell lines but not normal cells. D2 dopamine partial agonist PEGylated tablet formulation of naloxol (an analogue of naloxone) Fully human monoclonal antibody targeting interleukin17 (IL-17) Psoriatic arthritis, plaque psoriasis Copyright© PerformRx, LLC 2013 All Rights Reserved MARKET RELEASE Product (QIDP) designation for Apergillosis 12-2013; NDA submitted 72014 FDA breakthrough therapy designation 4-2013; Rolling BLA submitted 12014; FDA action date 10-28-14 NDA filed 42014: FDA priority review; FDA advisory cmte voted 11-2 against accelerated approval 625-2014; FDA action date still listed as 10-3-2014 NDA filed 32014; FDA priority review with action date 11-2014 NDA filed 7/14 NDA filed 9/13; FDA action date 9/16/14 BLA submitted 10/13 (plaque 194 PRODUCT MFR ROUTE INDICATION PHARMACOLOGY Umeclidinium bromide (Incruse Ellipta) GSK INH COPD Muscarinic acetylcholine (Ach) receptor antagonist Nintedanib (Vargatef) Boehringer Ingelheim PO Idiopathic pulmonary fibrosis, NSCLC, ovarian cancer Triple angiokinase inhibitor acting simultaneously on VEGFR, FGFR, PDGFR Albuterol multidose dry powder inhaler (Spiromax) Zarzio (filgrastim biosimilar) Teva INH Reversible obstructive airway disease Albuterol multi-dose dry powder inhaler (MDPI) Sandoz INJ (SC) Blood cell stimulator; neutropenia Neupogen biosimilar Asfotase Enobia pharma INJ (SC) Hypophosphatasia Recombinant fusion protein that includes catalytic domain of human tissue nonspecific alkaline phosphatase (TNSALP) Eliglustat (Cerdelga) Sanofi PO Gaucher’s disease Ruconest Salix INJ (IV) Hereditary angioedema Pirfenidone (Esbriet) InterMune PO Idiopathic pulmonary fibrosis (IPF), Partially inhibits the enzyme glucosylceramide synthase Complement C1r inhibitor-the major inhibitor of activated Hageman factor, plasmin and kallikrein of the coagulation pathway Small molecule tumor necrosis factor Copyright© PerformRx, LLC 2013 All Rights Reserved MARKET RELEASE psoriasis); FDA action date 10/20/14 FDA approved 4/30/14; launch planned for 4Q2014 NDA filed 7/14; orphan drug, fast track, priority review, and breakthrough therapy designation NDA filed 7/14 BLA submitted 7/14 (biosimilar pathway) FDA breakthrough therapy designation 5/28/13; rolling BLA initiated 4/25/14 NDA filed 12/13; FDA priority review 12/13 FDA approved 7/17/14; launch planned for late 2014 NDA submitted 195 PRODUCT MFR ROUTE INDICATION PHARMACOLOGY interstitial lung disease alpha (TNFalpha)inhibitor for inhibition of collagen synthesis; mitogenactivated protein (MAP) kinase p38 inhibitor Ferric citrate (Zerenex) Keryx PO Hyperphosphatemia Small-molecule phosphate binder Alemtuzumab (Lemtrada) Sanofi INJ(IV) Multiple Sclerosis Monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells Interferon-β with PEG (Plegridy) Biogen Idec INJ(SC) Multiple Sclerosis Hydrocodone ER (HYD, HydroContin) Purdue PO Moderate to severe pain Peglyated version of Avonex that allows every other week subcutaneous dosing Hydrocodone extended release with abuse deterrent properties; dosed once daily MNK-155 Mallinkrodt PO LP2086 (bivalent recombinant) Pfizer INJ (IM) Moderate to moderately severe acute pain Prevention of meningitis B Copyright© PerformRx, LLC 2013 All Rights Reserved Hydrocodone and acetaminophen extended release MARKET RELEASE 11/9; FDA complete response 5/10; FDA orphan drug status 2013; NDA resubmitted 5/27/14; FDA breakthrough therapy designation 7/17/14 NDA filed 8/13; FDA action date extended to 9/7/14 FDA complete response issued 12/13; Sanofi resubmitted 5/14; response expected 4Q2014 FDA approved 8/16/14 NDA submitted 4/14; FDA priority review; FDA action date 10/14 NDA submitted 5/14 FDA breakthrough therapy designation; NDA submitted 196 PRODUCT Multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero) MFR Novartis ROUTE INJ (IM) INDICATION Prevention of meningitis B Copyright© PerformRx, LLC 2013 All Rights Reserved PHARMACOLOGY Produced using reverse vaccinology, which decodes genetic makeup of MenB & selects proteins that are most likely to be protective vaccine candidates MARKET RELEASE 6/14 FDA breakthrough therapy designation; NDA submitted 6/14 197

July/August 2014

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