Sanofi will conduct a voluntary recall of Zantac OTC (over-the-counter) in the U.S. and Canada. This recall is being taken due to possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA). The company is working with health authorities to determine the level and extent of the recall.
On September 13, 2019, the U.S Food and Drug Administration (FDA) 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 (active ingredient) 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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Active ingredients used in Sanofi's ranitidine products outside of the U.S. and Canada are sourced from different suppliers. Sanofi is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence.
Sanofi encourages anyone using Zantac OTC to speak with their health care providers or pharmacists if they have any additional questions.