OTC Zantac Recall: Sanofi Heeds To Potential Ranitidine Contaminant

Firm opts for recall "as a precautionary measure due to inconsistencies in preliminary test results of the active ingredient used in the US and Canadian products." Other firms marketing ranitidine in US have started recalls due to concerns about NDMA since potential problem became known in September.

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Sanofi is following other firms in recalling ranitidine products available in the US due to the emerging threat of contamination with a nitrosamine impurity, N-nitrosodimethylamine (NDMA), a potential carcinogen.

More from Recalls

US FDA Questions Third-Party Labs’ Benzene Testing Methods As Acne Products Recalled

 
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FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.

Perrigo’s Formula To Drive Earnings Rebound Swings On Further Formula Business Recovery

 

“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

 

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

 

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”

More from Policy & Regulation

People On The Move: Appointments At Pharma Deutschland, MHRA, Futura

 
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A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.

Marketplace Results After FDA OTC Monograph Overhaul Rely On OMUFA Reauthorization

 

“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.

Democrats Torch Trump’s HHS Layoffs During House Hearing On OMUFA Reauthorization

 

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.