The U.S. 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., 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).
Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
The agency is testing ranitidine products from multiple manufacturers and assessing the possible effect on patients who have been taking ranitidine, as well as what manufacturers can do to reduce or eliminate nitrosamine in drugs.
As part of the FDA’s investigation, the agency recently posted a testing protocol, which can be used by regulators and industry to detect nitrosamine impurities in ranitidine. The FDA is asking companies to begin their own laboratory testing to examine levels of NDMA in ranitidine and to send samples of ranitidine to the FDA to be tested by agency scientists.
