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Sanofi recalls over-the-counter Zantac in US, Canada due to possible impurity

Sanofi is voluntarily recalling its over-the-counter heartburn medication Zantac in the U.S. and Canada, as a precaution against possible presence of an impurity called N-nitrosodimethylamine, or NDMA.

Paris-based Sanofi said it will determine the scope of the recall with the relevant health agencies, according to its Oct. 18 press release.

Sanofi is the latest in a line of drugmakers to pull Zantac off shelves after the U.S. Food and Drug Administration, Health Canada and the European Medicines Agency warned in September that the over-the-counter drugs, also available as generic ranitidine drugs, may contain NDMA, which is said to be a cancer-causing chemical.

Teva Pharmaceutical Industries Ltd., GlaxoSmithKline PLC, Mylan NV and Novartis AG have already recalled their generic ranitidine medicines.

NDMA was also found in batches of another heart medication known as sartan drugs in 2018, spurring global recalls and regulatory investigations of the contamination.