1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Recalls

OTC Zantac Recall: Sanofi Heeds To Potential Ranitidine Contaminant

 
• By Malcolm Spicer

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.

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
Start Free Trial

Already a subscriber?

More from Recalls

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

 
• By Lauren Nardella

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

 
• By Malcolm Spicer

“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

 
• By Malcolm Spicer

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

 
• By Malcolm Spicer

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

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.