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US FDA Questions Valisure’s Zantac Carcinogenicity Findings

Executive Summary

As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.

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USP Proposes Analytical Methods For Drug Makers To Detect Nitrosamine Impurities

The USP has launched an initiative to address the nitrosamine crisis by proposing a new general chapter that outlines a set of analytical methods that manufacturers can use to demonstrate their products are free from unsafe levels of these potential carcinogens. The chapter is aligned with the FDA’s guidance on nitrosamine impurities.

More Recalls Seen For Ranitidine

Sandoz is voluntarily recalling all ranitidine hydrochloride capsules in the US because of “confirmed’ NDMA contamination, while Dr Reddy’s is suspending global shipments of the generic version of Zantac due to worries about the presence of the suspected cancer-causing agent in its products, as suppliers around the world grapple with the issue.

Nordic Countries Join Race To Withdraw OTC Ranitidine

OTC presentations of ranitidine have been pulled from shelves in Denmark, Finland and Norway after the European Medicines Agency launched a review into the drug over safety fears.

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