Sanofi said Friday it will recall the widely-used heartburn drug Zantac from stores in the United States and Canada as the Food and Drug Administration investigates reports the drug contains a probable carcinogen.
The FDA last month said it discovered a probable carcinigen called NDMA, or nitrosodimethylamine, in the drug Zantac and its generic versions. The FDA, Canadian and European drug regulators are evaluating possible risk to millions of people who take ranitidine, the active ingredient in Zantac and its generic versions.
“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,” the company said in a statement.
The FDA has not called for Sanofi, which makes Zantac, or other generic manufacturers to recall any products from the market.
Preliminary tests detected levels of NDMA that equal or slightly exceed the amounts found in foods such as cured and grilled meats, said Janet Woodcock, an FDA official said last month.
The FDA has not recommend people stop taking the drug. However, the agency said people who want to discontinue prescriptions should talk to their doctor or pharmacist. Consumers who buy non-prescription versions can switch to other over-the-counter drugs; there are multiple drugs available for the same or similar uses, the FDA said.
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