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.

FDABldg64Lab_1200x675

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.

Sanofi's US office in Bridgewater, NJ, on 18 October said it will conduct a voluntary recall of its Zantac OTC in the US and Canada. While other firms marketing OTC...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Recalls

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

 
• By 

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

Haleon Study: Boosting Health Literacy Could Save Major Economies Over $300bn Per Year

 
• By 

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By 

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

US FDA Expands Surprise Foreign Inspections

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.