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Drugmaker Sanofi Recalls Heartburn Med Zantac


Drugmaker Sanofi Recalls Heartburn Med ZantacAP (File)
FILE - A box of Maximum Strength Zantac OTC tablets sits on a pharmacy shelf, Sept. 30, 2019, in Miami Beach, Fla.

Drugmaker Sanofi announced on Friday a voluntary recall of the heartburn drug Zantac from all stores in the United States and Canada amid investigations into the presence of a carcinogen discovered in the drug.

Sanofi's steps follow an investigation by U.S. and European regulators into the presence of low levels of the impurity N-nitrosodimethylamine (NDMA) in ranitidine, the generic name for the drug usually marketed as Zantac.

The same chemical has been linked to dozens of recalls of prescription blood pressure drugs in the past year.

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

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Pharmacies including CVS Health, Rite Aid, Walmart and Walgreens had all previously announced they would pull Zantac and its generic equivalents from its stores primarily out of an abundance of caution.

Two companies that produce generic versions of the drug — Sandoz, which is the generic unit of drug giant Novartis AG, and Apotex — already issued voluntary recalls of their versions of the drug.

Both companies said they haven't received any reports of patient harm. Some other manufacturers also stopped shipping their product to pharmacies.

Sanofi, which makes brand name Zantac, said it had been working with the FDA probe and conducting its own investigation into the contaminant as well. 

The FDA asks consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the scope of the problem. Visit the FDA MedWatch site here to complete and submit the form online. The form also can be downloaded from the site and faxed to 800-FDA-0178.