Additional ranitidine drugs being recalled

October 2, 2019

Health Canada is requesting companies stop distributing ranitidine drugs in Canada while it assesses NDMA.

Additional ranitidine drugs are being recalled by four companies: Apotex Inc., Pro Doc Limitée, Sanis Health Inc., and Sivem Pharmaceuticals ULC. The lots are being recalled as they may have been manufactured using an active pharmaceutical ingredient containing an impurity, N-nitrosodimethylamine (NDMA), above acceptable levels.

Please refer to the Affected Products table on the Health Canada Recalls and Safety Alerts website for detailed information on the recalled lots.

Health Canada is advising individuals to talk to their doctor or pharmacist about alternative, non-ranitidine treatment options appropriate for their health circumstances. Health Canada also advises that individuals who take prescription ranitidine drugs, including recalled products, should not stop taking them unless they have spoken to their health care provider and obtained an alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure.

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