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Category: Product Recall Management Best Practices

Oct
09

FDA’s Recall Planning Guidance Offers Little New Insight

FDA started issuing draft industry guidance related to Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) in January 2018, but the 16 chapters are still a work in progress. Most recently, the FDA alerted the industry in the federal register that Chapter 14: Recall Plan is now available. The PCHF guidance specifies that companies and organizations “must establish a written recall plan for food that requires a preventive control (21 CFR 117.139(a)).

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Jul
17

Breaking the Seal on Food Products: Transforming Protective Measures Into a Sales Advantage

When it comes to OTC pharmaceuticals and most personal care products, we’ve become accustomed to breaking layers of plastic bands, packaging seals and shrink-wrapped liners, whether opening a new bottle of ibuprofen or a fresh jar of moisturizer. When that seal is broken by someone other than us, we’re warned and conditioned to think that foul play has probably occurred. We understand that the product could be adulterated, contaminated or otherwise altered, rendering it unsafe.

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Jun
18

When Recalls Come Back to Haunt You

WYou identified a potential safety issue with your product and conducted an investigation. You worked closely with your regulator to plan for and execute a recall. Your team worked tirelessly to communicate with consumers and fix the issue. Then the regulator closed the recall. And you moved on. Or so you thought. The National Highway Transportation Safety Administration recently launched separate investigations into whether two GM recalls conducted years ago were inadequate.

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Jun
11

Recalls in the Era of Fake News

Fake product recalls – unlike other claims of so-called “fake news” – are exceedingly rare. But they are not without precedence. Just last year, a car dealership in Washington, D.C., was heavily fined by the Federal Trade Commission for sending fake recall warnings to car owners in the hopes of drumming up more business for the dealership’s repair shop. The dealership sent out bright red mailers that mimicked official recall notices from the National Highway Traffic Safety Administration (NHTSA).

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May
14

Pointing Fingers: Who’s Liable When a Defective Product Causes Harm

PA swift and thorough product recall is the best way to mitigate any legal liability risk from a defective product, removing inventory from the market before problems become pervasive. But in many cases, product defects or dangers aren’t discovered until after harm has occurred and liability cannot be avoided. Product liability laws enable consumers to sue those parties responsible when a product causes property damage, injury or death.

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