randy.curry@swosu.edu
09/09/2015 Medistat RX, LLC
08/27/2015 Miracle
08/24/2015 Fataway Ultimate
Stack, ThermoFX,
MaxOut Body,
Sterile Drug
Products
Dietary
Supplements
Dietary
Supplements
Sterility cannot be assured
Medistat
RX, LLC
These products contain the undeclared drug ingredient
Phenolphthalein and
Thiosildenafil
These products contain the undeclared drug
One
Minute
Miracle
Inc.
Novacare,
LLC http://www.fda.gov/
Safety/Recalls/ucm4
61939.htm
http://www.fda.gov/
Safety/Recalls/ucm4
60108.htm
http://www.fda.gov/
Safety/Recalls/ucm4
59817.htm

09/09/2015 Medistat RX, LLC Sterile Drug
Products
Sterility cannot be assured
Medistat
RX, LLC http://www.fda.gov/
Safety/Recalls/ucm4
61939.htm
Metabolic Accelerator,
Burn Fat Now,
Thermogenic Fat
Burner, Thin and Slim
Naturally, Extreme
Stack, Asia Black,
Black Widow 25, and
Methyldrene Original
25
08/24/2015 REFRESH®, FML® and Blephamide®
REFRESH®
Lacri-Lube®,
REFRESH
P.M.®, FML®
(fluorometholone ophthalmic ointment) and
Blephamide®
(sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) ingredient salicylic acid making these unapproved new drugs
Contains particulate matter
August 25, 2015
Allergan plc http://www.fda.gov/
Safety/Recalls/ucm4
59499.htm

Meropenem for Injection, USP ( Currently in Shortage )

Cefepime Injection ( Currently in Shortage )

Cefepime Injection ( Currently in Shortage )

Levetiracetam (Keppra) Injection ( Currently in Shortage )

Morphine Sulfate (Avinza) Extended Release Capsules ( Discontinuation )

Epinephrine 1mg/mL (Preservative Free) ( Currently in Shortage )


Sacrosidase (Sucraid) Oral Solution ( Currently in Shortage )

Caffeine Anhydrous (125mg/mL); Sodium Benzoate (125mg/mL) Injection ( Currently in Shortage )

Calcium Gluconate Injection ( Currently in Shortage )

Levetiracetam (Keppra) Injection ( Currently in Shortage )

Acamprosate Calcium (Campral) Delayed Release Tablets, 333 mg ( Discontinuation )

Calcium Chloride Injection, USP ( Currently in Shortage )

Cefazolin Injection ( Currently in Shortage )

Cefepime Injection ( Currently in Shortage )

Dextrose 5% Injection Bags ( Currently in Shortage )

Dextrose Injection USP, 70% ( Currently in Shortage )

Epinephrine Injection ( Currently in Shortage )

Fentanyl Citrate (Sublimaze) Injection ( Currently in Shortage )

Levetiracetam (Keppra) Injection ( Currently in Shortage )

Lidocaine Hydrochloride (Xylocaine) Injection ( Currently in Shortage )

Magnesium Sulfate Injection ( Currently in Shortage )

Memantine Hydrochloride (Namenda) Tablet ( Discontinuation )

Piperacillin and Tazobactam (Zosyn) Injection ( Currently in Shortage )

Potassium Chloride Injection ( Currently in Shortage )

Sodium Chloride 0.9% Injection Bags ( Currently in Shortage )

Tobramycin Injection ( Currently in Shortage )

L-Cysteine Hydrochloride Injection ( Currently in Shortage )

Reserpine Tablets ( Currently in Shortage )

FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain o http://www.fda.gov/Drugs/DrugSafety/ucm459579.htm

Office for Civil Rights Selects Vendor for Next Round of HIPAA Audits – Five Things You Should Do to
Prepare o http://www.jdsupra.com/legalnews/office-for-civil-rights-selects-vendor-
44316/?utm_source=JD-Supra-eMail-Digests


Alerts FDA expands warning on Becton-Dickinson (BD) syringes being used to store compounded or repackaged drugs and Notices o http://www1.bd.com/alerts-notices/ o http://www.fda.gov/Drugs/DrugSafety/ucm458952.htm?source=govdelivery&utm_medium= email&utm_source=govdelivery
 Common Antibiotic Spurs Rare But Deadly Neurotoxicity o http://www.empr.com/drug-monograph-updates/section/1776/
 July 2015 Recap of Drug Updatesfrom MPR o http://www.empr.com/drug-monograph-updates/july-2015-recap-of-drugupdates/article/427808/ o Drug Safety Labeling Changes

The MedWatch August 2015 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS,
ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
o The "Summary Page" table provides a listing of product names and safety labeling sections revised: o http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm460662.htm
Actimmune (Interferon gamma-1b)
Adcetris (brentuximab vedotin)
Botox (onabotulinumtoxin A)
Copegus (ribavirin) Tablets
Daytrana (methylphenidate transdermal system)
Geodon (ziprasidone hydrochloride) Oral Suspension
Geodon (ziprasidone mesylate) Injection
Geodon (ziprasidone) Capsules
Gilenya (fingolimod) Capsules
Glyxambi (linagliptin and empagliflozin)
Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride)
Implanon (etonogestrel implant)
Janumet (sitagliptin and metformin)
Janumet XR (sitagliptin and metformin extended release)
Januvia (sitagliptin)
Jentadueto (linagliptin and metformin)
Kazano (alogliptin and metformin)
Kombiglyze XR (saxagliptin and metformin extended release)
Lotensin HCT (benazepril hydrochloride/hydrochlorothiazide) Tablets
Mircera (methoxy polyethylene glycol-epoetin beta)
Myrbetriq (mirabegron) Extended-release Tablets
Nesina (alogliptin)
Nexplanon (etonogestrel implants)
Onglyza (saxagliptin)
Oseni (alogliptin and pioglitazone)
Prestalia (perindopril arginine/amlodipine besylate) Tablets
Prinivil (lisinopril) Tablets
Sovaldi (sofosbuvir) Tablets
Sprycel (dasatinib) Tablets

Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, and Tegretol-XR (carbamazepine extended-release) Tablets
Thalomid (thalidomide) Capsules
Tivicay (dolutegravir) Tablets
Tradjenta (linagliptin)
Triumeq (abacavir/dolutegravir/lamivudine)
Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets
Vasotec (enalapril maleate) Tablets
Xenical (orlistat) Capsules
Xtandi (enzalutamide) Capsules
Zelboraf (vemurafenib) Tablets
Zestoretic (lisinopril/hydrochlorothiazide) Tablets
Zestril (lisinopril) Tablets http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm460662.htm?source=govdelive ry&utm_medium=email&utm_source=govdelivery

5 dengue vaccines in development
http://www.healio.com/infectious-disease/emerging-diseases/news/online/%7Bfcdcf553-a411-
4496-b452-ec7048e5d37d%7D/5-dengue-vaccines-in-development

Compensation Growing for Botched Vaccine Administration
-See more at: http://www.pharmacytimes.com/news/compensation-growing-for-botched-vaccineadministration?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=PT%5Fe
News%5FDaily%5F9%2D11%2D15#sthash.WaZ1sjld.dpuf
http://www.pharmacytimes.com/news/compensation-growing-for-botched-vaccineadministration?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=PT_eN ews_Daily_9-11-15

The Definition of Identify: The 60-Day Rule o http://www.jdsupra.com/legalnews/the-definition-of-identify-the-60-day-13032/?utm_source=JD-
Supra-eMail-Digests
Unique Aspirin Formulation Gets FDA Nod for Secondary Prevention of Stroke, Cardiac Events http://www.empr.com/news/durlaza-approved-24-hour-extended-releaseaspirin/article/437257/?DCMP=EMC-
MPR_breakingnews_cp&cpn=mylan_2014,strib_pharm,strib_mobile&hmSubId=&hmEmail=zc9
AEZF4x4rPbtLJAxJhmklDzcJVA8s10&NID=&dl=0&spMailingID=12343671&spUserID=NDgy
NTEwMTE5NjYS1&spJobID=620567179&spReportId=NjIwNTY3MTc5S0
******************************************************
This content is copyright protected
However, if you would like to share the information in this article, you may use the headline, summary and link below:
AstraZeneca signs dendrimer drug delivery deal with Australian tech firm
By Dan Stanton+ , 07-Sep-2015

AstraZeneca has licensed Starpharma’s Dendrimer Drug Delivery (DEP) platform to enhance the pharmaceutical properties in candidates in its oncology pipeline. http://www.in-pharmatechnologist.com/Product-Categories/Delivery-technologies/AstraZeneca-signsdendrimer-drug-delivery-deal-with-Starpharma
******************************************************
This content is copyright protected
However, if you would like to share the information in this article, you may use the headline, summary and link below:
AstraZeneca signs dendrimer drug delivery deal with Australian tech firm
By Dan Stanton+ , 07-Sep-2015
AstraZeneca has licensed Starpharma’s Dendrimer Drug Delivery (DEP) platform to enhance the pharmaceutical properties in candidates in its oncology pipeline. http://www.in-pharmatechnologist.com/Product-Categories/Delivery-technologies/AstraZeneca-signsdendrimer-drug-delivery-deal-with-Starpharma
*******************************************************
This content is copyright protected
However, if you would like to share the information in this article, you may use the headline, summary and link below:
AstraZeneca signs dendrimer drug delivery deal with Australian tech firm
By Dan Stanton+ , 07-Sep-2015
AstraZeneca has licensed Starpharma’s Dendrimer Drug Delivery (DEP) platform to enhance the pharmaceutical properties in candidates in its oncology pipeline. http://www.in-pharmatechnologist.com/Product-Categories/Delivery-technologies/AstraZeneca-signsdendrimer-drug-delivery-deal-with-Starpharma

CMS Emphasizes Upcoming ICD-10 Transition Date o http://www.jdsupra.com/legalnews/cms-emphasizes-upcoming-icd-10-
15685/?utm_source=JD-Supra-eMail-Digests

Association of 12 h shifts and nurses’ job satisfaction, burnout and intention to leave: findings from a cross-sectional study of 12 European countries o http://bmjopen.bmj.com/content/5/9/e008331.full

EPA Proposes New Standards for Hazardous Waste Pharmaceuticals o http://www.jdsupra.com/legalnews/epa-proposes-new-standards-for-
36894/?utm_source=JD-Supra-eMail-Digests

New Tests Rapidly Detect Drug-Resistant TB o http://www.consultant360.com/exclusives/new-tests-rapidly-detect-drug-resistanttb

Too Much, Too Little Sleep May Harm the Heart, Sound slumber 'recharges our batteries,' cardiologist explains o https://www.nlm.nih.gov/medlineplus/news/fullstory_154563.html

FDA Committees Vote No to New Oxycodone IR Formulation o http://www.empr.com/news/fda-committees-vote-against-avridi/article/438153/?DCMP=EMC-
MPR_DailyDose_cp&cpn=mylan_2014,strib_pharm,strib_mobile&hmSubId=&hmEmail=zc9AEZF4x4rPbtLJAxJh

mklDzcJVA8s10&NID=&dl=0&spMailingID=12379300&spUserID=NDgyNTEwMTE5NjYS1&spJobID=620804
475&spReportId=NjIwODA0NDc1S0