From the Government of Canada, updated Oct 18, 2019: “Additional prescription and over-the-counter ranitidine drugs, including Zantac, are being recalled by Sanofi Consumer Health Inc., Sivem Pharmaceuticals ULC and Teva Canada Limited because they may contain the impurity N-nitrosodimethylamine (NDMA) above acceptable levels. Please refer to the Affected Products table … for detailed information on the recalled lots.”
From Wikimedia (extracted Oct 19, 2019: “NDMA is water-soluble, yellow in color, and its taste and odor are weak or absent. It is toxic to the liver and other organs, and is a human carcinogen. It is also used to create cancer in rats for cancer research.”
From Sanofi, Oct 18, 2019:
As a precautionary measure, Sanofi will conduct a voluntary recall of Zantac OTC (over-the-counter) in Canada and the U.S. This recall is being taken due to possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA) and will be initiated, in Canada, at the pharmacy and retail store level.
On September 13, 2019, Health Canada and the U.S Food and Drug Administration 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 U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in Canada and the U.S. as the investigation continues.
Active ingredients used in Sanofi’s ranitidine products outside Canada and the U.S. 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 pharmacist if they have any additional questions.
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SOURCE Sanofi-Aventis Canada Inc.