Voluntary recall of Sandoz ranitidine capsules following detection of impurity

The US Food and Drug Administration is alerting health care professionals and patients of a  voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc, the biosimilars and generics unit of Swiss pharma giant Novartis (NOVN: VX), used to decrease the amount of acid created by the stomach.

This recall is due to a  nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer).

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We began testing ranitidine products immediately after we learned of the potential impurity. When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said Acting FDA Commissioner Dr Ned Sharpless, adding: “We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern.”