OTC Zantac And Private Label Ranitidine Numerous In FDA Recall Updates

In addition to Sanofi, firms recalling OTC ranitidine products with documentation included in FDA's database updates through 9 January are Amneal Pharmaceuticals, Preferred Pharmaceuticals, which distributed products made by Amneal, and Granules India Ltd.

Product Recall, man writing on transparent screen - Image

Sanofi's recall of OTC Zantac due to contamination of the active ingredient ranitidine with a potential carcinogenic is so widespread the US Food and Drug Administration's documentation of the firm's actions doesn't identify quantities of containers or packages but refers only to "all lots" of the products.

Information on some other firms' recalls for private label and store brand copies of OTC Zantac in 75- and 150-mg ranitidine formulations added to the FDA's recalls database between mid-December and 8 January also doesn't include amounts, which the agency's typically does in its recall records

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