Oct. 18 (UPI) -- Pharmaceutical company Sanofi announced Friday it's recalling over-the-counter Zantac a month after the Food and Drug Administration said the heartburn drug contains small amounts of a carcinogen.
Sanofi described the voluntary recall as a "precautionary measure." The company said it's working with federal health officials to determine the extent of its recall.
The recall affects Zantac OTC products sold in the United States and Canada.
"Evaluations are ongoing on both drug substance (active ingredient) and finished drug product," Sanofi said in a statement. "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 announcement comes nearly three weeks after Apotex, the maker of a generic version of the drug issued its own recall. The FDA said preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine in some ranitidine products.
The medication is used to treat heartburn, ulcers and other stomach issues. Walmart halted all sales of Zantac and generic versions of ranitidine after the FDA report.
NDMA is the same contaminant found in many brands of blood pressure and heart failure medicines during the past year, leading to recalls. NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables. It is classified as a probable human carcinogen.
The FDA said it's evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and that it will post that information when it's available.
Large amounts of NDMA may pose a risk, but the levels of NDMA in ranitidine found in preliminary tests barely exceed amounts found in common foods, according to the FDA.