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Category: Pharmaceutical Industry

Nov
13

Product Recalls Stabilize, But an Upsurge is Expected

By Chris Harvey Tags: automotive recalls, consumer product safety, food recall trends, medical device recalls, pharmaceutical recall, Recall Index, Stericycle Expert Solutions, Stericycle Recalls,

While U.S. product recalls were relatively flat from the second to third quarter, expect an upsurge in the weeks and months to come as regulators – under growing pressure from Congress and consumer groups – turn their attention to currently unregulated categories.  Part of that pressure on regulators is a result of past handling of product safety issues.

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Nov
07

It’s Official: Active Pharmaceutical Ingredient Makers in FDA’s Crosshairs

By Chris Harvey Tags: API, Association for Accessible Medicine, FDA, NDMA, Pharma, Supply chain,

If there was any doubt whether the entire active pharmaceutical ingredient (API) industry is a target for continued FDA scrutiny, it should be gone. Donald Ashley, director of FDA’s Office of Compliance, talked about major concerns the agency has with the API industry at the Association for Accessible Medicines’ conference. As reported in an

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Oct
22

Cannabis Recalled Without Federal Regulation

By Chris Harvey Tags: Cannabis, cbd, CBD Oil, Commissioner Scott Gottlieb, DEA, FDA, federal regulation, risk assessment,

The product recall by Denver-based marijuana cultivator Bonsai Cultivation reminds us all of the unique regulatory dynamic facing the cannabis industry. In this case, the cultivator – working with state officials – pulled marijuana products off the market because they may contain elevated yeast and mold counts. The recall followed a Denver Department of Public Health & Environment examination of dried marijuana samples.

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Oct
09

FDA’s Recall Planning Guidance Offers Little New Insight

By Amanda Combs Tags: FDA, food safety, Product Safety, recall planning, Recall Plans, Stericycle Expert Solutions,

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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Sep
25

Investigation Underway, Generic Zantac Shipments Stopped. Recall Next? Almost Undoubtedly

By Matt Walker Tags: FDA, Recall, Sanofi, Torrent Pharmaceuticals, Zantac,

Bloomberg News recently published a lengthy piece on how carcinogens are allegedly infiltrating the generic drug supply in the United States. The very next day, drug safety officials announced that they were investigating whether Zantac and its generic counterparts contain levels of the probable carcinogen N-Nitrosodimethylamine, or NDMA – the same chemical that was found in blood-pressure pills last year. Those pills were ultimately recalled, and those

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