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Sanofi To Recall Zantac In North America

Sanofi plans to conduct a voluntary recall of Zantac over-the-counter drugs in the U.S. and Canada, due to a possible contamination with a nitrosamine impurity called N-nitrosodimethylamine.

The company said it is working with health authorities to determine the level and extent of the recall.

On September 13, the U.S Food and Drug Administration and Health Canada issued public statements alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing.

Evaluations are ongoing on both drug substance and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues.

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