Oct. 23 (UPI) -- Pharmaceutical company Dr. Reddy's Laboratories on Wednesday recalled heartburn relief products it makes with ranitidine after the Food and Drug Administration said the drug contains small amounts of a carcinogen.
The India-based company said it was pulling all medications with ranitidine from U.S. shelves. The company makes generic, store-brand versions of pharmaceutical company Sanofi's Zantac OTC.
Among the brands affected by the recall are Sam's Club, Walgreens, Walmart, Kroger, CVS, Target, Thirty Madison, CDMA, HCA, Dr. Reddy's and GeriCare. A full list of the recalled products was published on the FDA's website.
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, and drugmakers Apotex and Sanofi issued recalls.
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.
