US FDA Questions Valisure’s Zantac Carcinogenicity Findings
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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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.
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.
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.