Heartburn medication Zantac recalled in Canada and USA over contamination fears

Cornelia Mascio
Ottobre 21, 2019

This recall has now been updated to include an additional three companies and their heartburn drugs, all suspected of having the same potential impurity.

Because its own testing hasn't give a clear answer so far, the company said, "Sanofi has made the decision to conduct the voluntary recall in the US and Canada as the investigation continues".

The Food and Drug Administration (FDA) yesterday said that 420 batches of 23 ranitidine drug products that allegedly contain the potentially carcinogenic n-nitrosodimethylamine (NDMA) must be recalled by November 18.

Health Canada also said it was investigating the possible presence of a carcinogen in some ranitidine drugs available by prescription and over-the-counter.

As NDMA is classified as a likely human carcinogen, it launched an inspection to test ranitidine products from multiple domestic manufacturers, the FDA said.

However, the report does confirm that the recalled heartburn drugs are expected to have NDMA levels that exceed these safe, low doses.

Drugmaker Sanofi is voluntarily recalling of the heartburn medication Zantac OTC.

A list of the products and batch numbers that have been recalled can be found on the FDA's official Web site, www.fda.gov.tw, under the "stomach medicine abnormal events information" section on the Chinese-language main page.

Health Canada is advising consumers who take a ranitidine medication to speak with their doctor or pharmacist about an alternative treatment option.

Health Canada says they are working to review the issue of NDMA and other contaminants in blood pressure medications. The risk of not treating the condition may be greater than the risk related to NDMA exposure.

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