Lavonne Kucera
Corporate Director
Quality Assurance
Product Recalls: A- Z
CONFIDENTIAL
Recalls A-Z
Raw Alfalfa Sprouts Linked to Salmonella Contamination
Sat, 25 Apr 2009 23:00:00 -0500
The U.S. Food and Drug Administration (FDA) and the
Centers for Disease Control and Prevention (CDC) today
recommended that consumers not eat raw alfalfa sprouts,
including sprout blends containing alfalfa sprouts, until
further notice because the product has been linked to
Salmonella serotype Saintpaul contamination
Recalls A-Z
FDA Alerts Consumers to Recall of Certain Pistachios
Sun, 29 Mar 2009 23:00:00 -0500
The FDA and the California Department of Public Health
(CDPH) are investigating Salmonella contamination in
pistachio products sold by Setton Pistachio of Terra Bella
Inc, Calif.
Recalls A-Z
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March 16, 2009 - Texas Star Nut & Food Company Announces
Voluntary Recall of Raw Peanuts Due to Potential Health Risk
March 16, 2009 - Grower's Outlet Recalls Honey Roasted
Peanuts Because of Possible Health Risk
March 16, 2009 - Ultimate Nut and Candy Co. Recalls, Sugar
Free & Low Carb Peanut Butter Cups, Peanut Butter Crisp (a
chocolate bark), and Peanut Butter Jars Because Of Possible
Health Risks
March 14, 2009 - Jay Robb Enterprises Inc. Voluntarily Recalls
Peanut Butter JayBars
March 13, 2009 - Kerry, Inc. Expands Voluntary Recall of Peanut
Products Following Expanded FDA Investigation of Peanut
Corporation of America
March 13, 2009 - Weaver Popcorn Company Issues a Nationwide
Precautionary Voluntary Recall of 12 oz. (340g) Trail's End®
Chocolatey Peanut Clusters
March 13, 2009 - Asia Cash and Carry Recalls Crown Farms
Brand "Gulsha" Fish Because of Possible Health Risk
Recalls A-Z
Statistics:
• 73 million people a year become ill from food
• 350,000 are hospitalized
• 5,000 deaths
• Less than 10% of food borne illness is reported
Recalls A-Z
• When is a Recall required?
– When a product is misbranded or misrepresented
• Health definitions such as “light” or “lite”, “low fat”, etc
• Weights are not as declared
– When a product is adulterated:
• Foreign material
• Chemical contamination
• Microbiological contamination
• Package labeling does not follow Food Code
• Ingredients decks are incorrect
• Undeclared allergens
Recalls A-Z
Allergens:
LeClerc Foods Announces a Limited Nationwide Voluntary
Recall of Market Pantry Chocolate Chip Chewy Granola
Bars due to Unlabeled Peanut Allergen
Mon, 04 May 2009 23:00:00 -0500
LeClerc Foods Announces a Limited Nationwide Voluntary
Recall of Market Pantry Chocolate Chip Chewy Granola
Bars due to Unlabeled Peanut Allergen
Food Allergens
What is a food allergy?
• A food allergy is an immune system response to a food that
the body mistakenly believes is harmful.
What is a food allergen?
• A food allergen is a food product that triggers an allergic
response in the body.
Food Allergens
The “Big 8”
– Eight most common allergenic foods
– Account for 90 percent of food allergic reactions
– Include:
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Milk
Eggs
Peanuts
Tree nuts (almonds, walnuts, pecans)
Wheat
Soybeans
Fish (bass, flounder, cod)
Crustacean shellfish (crab, lobster, shrimp)
Food Allergens
Statistics:
• In the U.S., more than 4 million people have food allergies
• Each year, food allergies are believed to cause:
– 30,000 emergency room visits
– 2,000 hospitalizations
– 150 deaths
Recalls A-Z
• FDA
– over 600 recalls to date in 2009
– Approximately 4 recalls every day
• USDA
– 33 recalls to date in 2009
– 12 closed with over #100,000 product identified
– 21 cases remain active
Recalls A-Z
• Who Requests a Recall?
• What is it the difference between a Recall and a Voluntary
Recall?
• Who is responsible for carrying out a Food Recall?
• What is the difference between a
– Recall
– Market Withdrawal
– Stock or Inventory Recovery
• Public Notice – who puts them out
• How to close a Recall?
Recalls A-Z
Initiating a recall…..
Recalls A-Z
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Regulated product
– USDA: meat, poultry and eggs
– FDA: all other food including seafood, water, and non-food related
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Protect the consumer
– Remove items that may cause temporary or irreversible health
consequences
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Protect the Brand
– Suppliers
– Manufacture
Recalls A-Z
1st celebrity falls victim to Swine Flu….
Recalls A-Z
Recalls A-Z
Recalls begin in one of two ways:
• Company discovers a problem with product
– Company production records, routine testing, etc.
– Customer Complaint process
• Regulatory Agency (FDA, USDA)
– Routine destination or origin testing
– Conducted by Federal Agency, military, State or local health
departments
Terminology
Recall/Voluntary Recall
Removal of product that has left the firm’s control, distributed in
interstate commerce and there is reason to believe the product is
adulterated or misbranded within the meaning of the Federal Food
Code.
• Recall does not include a market withdrawal or stock recovery
Terminology
Market Withdrawal
Firm’s voluntary removal of distributed product that exhibits a
minor company quality issue or regulatory program infraction
that would not cause the product to be adulterated or
misbranded.
• Defect would not be subject to FDA regulatory action
• i.e.: product does not meet company quality standards
due to discoloration
Terminology
Stock or Inventory Recovery
Removal or correction of product that has not been marketed
or has left the direct control of the firm
• Product has not been marketed, or sold to a secondary
party
• Must be located on the premises owned by the producing
firm or under it’s control
• All product can be accounted for and has not been
released for sale or use
Classifications
FDA/USDA (FSIS) Classifications:
– Class I : Reasonable probability that use or exposure would
cause serious adverse health consequences or death
• i.e.: product contaminated with glass
– Class II: Use may cause temporary or medically reversible
adverse health consequences
• i.e.: presence of undeclared allergens
– Class III: Use is not likely to cause adverse health
consequences
• i.e.: presence of an undeclared, generally recognized as
safe substance
• i.e.: product not meeting specification, such as weight
Depth of Recall
• Wholesale level
– Product has been distributed to a warehouse of distribution
center and it is not under the control of the manufacture
• Retail Level
– Product is at retailers, but has not been sold to consumers
• HRI Level
– Product is at hotels, restaurants or other institutional
customers
• Consumer Level
– Product has been sold to consumers, some product may
remain under control of the retailer.
Recalls
Who Requests a Recall?
– Regulatory Agency (FDA, USDA)
– Military, local and State Health Departments
via Regulatory Agency
– Supplier of ingredients
– Manufacturer of finished goods
Recalls
• What is the difference between a Recall and a Voluntary
Recall?
– Recall: initiated by regulatory agency when the manufacturer
does not initiate the removal of adulterated product.
• FDA has the power to institute a seizure of food via court
order that it believes is adulterated or misbranded
• USDA inspectors can withdraw from inspected facilities,
effectively banning product from interstate commerce
• Order manufacturing to stop until compliance with Code of
Federal Regulations is met
• Detention and seizure of product in commerce
• Initiates a recall letter and media notification
– Voluntary Recall: initiated by the manufacturer
Recalls
• Who is responsible for carrying out a Food Recall?
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Manufacturer of the adulterated finished product
Supplier of ingredients
Distributor
Warehouses
Retail Stores
Regulatory Agencies (Federal, State, Health, etc.)
Media
Consumers
Recalls
Focus on Manufacture’s or Suppliers Responsibilities..
Manufacture Responsibilities
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Key Recall Steps:
– Determine the extent of the affect product by lot, quantity, customers,
states, etc. via production and distribution records
– Initiate the voluntary recall with the Federal Agency
– Notify consumer, further processing agents, distributors, warehouses
– Track action of all that handle product
– Assure proper destruction of affected product
Manufacture Responsibilities
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Key Recall Steps continued:
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Conduct Effectiveness Checks
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Handle Media inquiries
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Handle consumer concerns and questions
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Conduct daily update meetings with Recall team
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Determine root cause and implement corrective action
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Clear production to produce safe, wholesome product to fill pipeline
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Maintain accurate records of actions taken and request closure of recall
Manufacture Recall Responsibilities
In Depth Look:
– Determine the extent of the affect product by lot, quantity,
customers, states, etc. via production and distribution records
– Determine root cause and implement corrective action
– Clear production to produce safe, wholesome product to fill
pipeline
– Maintain accurate records of actions taken and request
closure of recall
Manufacture Responsibilities
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Validation of product name and loting to production records
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Lot tracking of inbound ingredients
– Quantities received vs. shipped from manufacture
– Dates received with quantities
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Production Records
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Date(s) when ingredient utilized
Names of finished product(s) that are affected
How much was produced
What are the affected lots
Product remaining in inventory or warehouse
Quantity in process (WIP), R&D, etc
Rework
Waste calculations
Quantity in carry over
Other items that were run same day or same equipment – clean to
clean
Manufacture Responsibilities
• Shipment records
– Dates finished goods received into inventory
– Inventory reconciliation records
– Quantities shipped vs inventory in freezer/refrigerated
warehouse, distribution centers
– Damaged goods, samples, employee purchased, etc
– PO or Customer shipment lists
– Items in transit
• Quarantine inventory at facilities, warehouses,
distribution centers
– Remove and physically HOLD
– Deplete any electronic inventory system
Manufacture Responsibilities
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Determine root cause of adulterated or misbranded product
– HACCP Review
– Validate and implement corrective action
• Swabbing records, additional swabs to find source
• Engineering for PM, equipment disassembly/reassembly
• Sanitation for records, personnel and on demand cleaning
• Floor personnel for common links
– Resources
• Food Safety extension
• Regulatory Agents
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Clear production to manufacture
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COA’s on in-bound ingredients
Elevated Environmental Swabbing
HOLD & test
Finished goods testing
Manufacture Responsibilities
• Maintain accurate records of action
– Potential causes
– Actions taken
– Conclusions
• Work with regulatory agency on daily basis
– In plant program and record review
– Facility swabbing and monitoring
• Establish Recall communications…
Communications
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Distribution channels
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Warehouses
On-line customers
Retail stores
Public Notice
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Voluntary Recall: Initiating firm issues the press release with approval of
USDA/FDA
All Class I recalls must have a press release
Regulatory agency sends to Associated Press
Recalling firm can send directly to affected states for inclusion
Posted on FDA’s website: www.fda.gov
FDA weekly publication entitled “Enforcement Reports”
USDA (FSIS) posts on Recall Notification report
Communications
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Clear and concise is key
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Why the product is being recalled (may be contaminated with...)
Brand Names product can be recognized as
Name of the product as found on package
Name of company recalling product
Loting of the product being recalled (use by, sell by, etc)
Risks involved in consuming products;
• symptoms and people that are at risk
Directions on what to do with product
• Return to store
• Hold for pick up for central destruction
– Certificate of Destruction at landfill, notify Regulatory Agency
• Properly destroy adulterated product
– Deface package and destroy contents
Consumer contact information
Media contact information, name and number
Nestlé USA’s Baking Division Initiates Voluntary Recall
Contact:
Laurie MacDonald
(818) 549-6235
Roz O’Hearn
(440) 264-5170
FOR IMMEDIATE RELEASE -- Solon, OH - June 19, 2009 - Nestlé USA’s Baking Division is initiating a voluntary recall
of Nestlé® TOLL HOUSE® refrigerated cookie dough products. Nestlé is taking this action out of an abundance of
caution after being notified that the Food and Drug Administration, together with the Centers for Disease Control, are
conducting an investigation into reported E. coli 0157:H7 illnesses that may be related to consumption of raw cookie
dough.
A number of consumers reporting illness reported consuming raw Nestlé TOLL HOUSE refrigerated cookie dough.
While the E. coli strain implicated in this investigation has not been detected in our product, the health and safety of our
consumers is paramount so we are initiating this voluntary recall. We have been and will continue to cooperate fully with
the Food and Drug Administration and the Centers for Disease Control in this investigation. Providing safe, high quality
products to our consumers is our number one priority.
No other Nestlé TOLL HOUSE products are impacted, including already baked TOLL HOUSE cookies purchased
outside the home, all varieties of Nestlé TOLL HOUSE morsels, chocolate baking bars, or cocoa, and Dreyer’s and
Edy’s ice cream products with Nestlé TOLL HOUSE cookie dough ingredients.
We want to strongly advise consumers that raw cookie dough should not be eaten. This message also appears
prominently on our packaging. Nestlé TOLL HOUSE cookies made from refrigerated dough are safe to consume when
baked as directed on the package. Consumers who have purchased these products should not consume them. Instead,
we are asking that consumers return these products to their local grocer for a full refund. We invite consumers with
questions to contact Nestlé Consumer Services at 1-800-559-5025 and visit our web site at www.verybestbaking.com.
The products involved in the voluntary recall include all varieties of Nestlé TOLL HOUSE refrigerated Cookie Bar
Dough, Cookie Dough Tub; Cookie Dough Tube; Limited Edition Cookie Dough items; Seasonal Cookie Dough and
Ultimates Cookie Bar Dough. Variety information is included in the list below.
Description
Nestle Toll House Cookie & Brownie DoughConsumer
Unit Code (UPC) COOKIE & BROWNIE DOUGH BAR Chocolate Chip bar 16.5oz0 50000 62231 3Chocolate Chip bar
16.5oz 0 50000 11308 ………
Closing a Recall
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Effectiveness Checks
– Recalling firms means of evaluating how effective the recall process
was in notifying direct customers of the recall and assuring it was
read, understood and followed.
• Verifies recall reached the appropriate level in the distribution
chain
• If not effective, a second communication notice should be sent
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Effectiveness checks are:
– Conducted by the initiating firm
– Validated by Regulatory Agency
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Methods
– Consignee lists
– Set of questions to verify notice was received and followed
– Can be conducted via mail, telephone, personal visit or via returned
electronic methods such as e-mail or fax
Closing Recalls
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Initiating firm requests close from governing agency
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Written closure to include:
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Name of firm requesting closure
Information regarding recalled product (name, package info, etc.)
Why product was originally recalled
Amount of product recovered
Where product was recovered from by type of business;
• Warehouse
• Distributors
• Stores
• Consumers
How product was destroyed, include letter of destruction if necessary
Action taken to assure process deviation that caused recall has been
corrected
Method and percent effectiveness checks
When firm believes all product was out of the market
Any reports of customer illness
Closing Recall
• Governing agency;
– Conduct Effectiveness checks
– Visit processing site to assure corrections have occurred
– Issue closure if recall actions taken have been satisfactory
Recall Learning’s
• Communication is critical
– Receiver needs to understand action required
– Distributors through retail stores must have solid
practices in place so product does not end up back in
out-bound inventory
• Retail and Consumers do not always heed…
– Communication for following required steps
• Stores may be busy
• Personnel understanding of need to act
– Loting information with size and manufacture codes
• Complicated – pull it all
Recall Learning’s
• Understand the risk associated with ingredients
• Manage suppliers to control potential risks “you are only as
good as your suppliers”
• Watch carry over and rework process…
Recall Learning’s
• Third party audits do serve a purpose, but understand they
are usually announced, paid for, snap shot in time
inspections. Read the fine print!
• Distribution chain has emergency information for key
contacts
Recalls A-Z
• Recalls are Common
– In 2009, approx 4 per day
• Have a solid recall program in place, people understand
their roles and practice for preparedness
– Practice, practice, practice
– Emergency contacts
– Model letters and notices prepared in advance
Recalls A-Z
Work together to remove adulterated product
THANK YOU!
Lavonne Kucera
CONFIDENTIAL
Product Recalls: A-Z