September 30, 2019
CVS Health Corp., Walgreens and Rite-Aid have suspended sales of Zantac and generic versions of ranitidine due to safety concerns raised by the U.S. Food and Drug Administration.
The FDA is investigating whether the low levels of a probable carcinogen found in ranitidine pose a risk to patients. A voluntary recall of some generic versions was issued last week.
Ranitidine is a common heartburn medication sold under the brand name Zantac. It comes in both over-the-counter and prescription forms.
The probable carcinogen, N-nitrosodimethylamine (NDMA), is an environmental contaminant found in water and foods, including meats, dairy products and vegetables, according to the FDA.
Zantac brand and CVS ranitidine products have not been recalled, nor has the FDA recommended that patients cease taking ranitidine. But CVS issued is removing the products from its shelves "out of an abundance of caution," a company statement said.
CVS will continue selling other over-the-counter heartburn relief medications, including Pepcid, Tagamet and their respective generic versions.
A Walgreens spokesperson told ABC News that the retailer also was "removing Zantac and ranitidine products from our shelves while the FDA continues its review of the products." Rite-Aid is doing likewise, NBC reported.
Last week, Sandoz recalled 14 lots of prescription ranitidine hydrochloride capsules determined to have elevated levels of NDMA.
The FDA is working with international regulators to determine whether ranitidine products contain dangerous amounts of NDMA. Preliminary testing found levels barely exceeded the amount found in common foods, the FDA said last month.