Ranitidine recalled due to nitrosamine impurity
American Health Packaging recalled 11 lots of the histamine-2 receptor antagonist due to the potential presence of excess amounts of N-nitrosodimethylamine, a probable carcinogen.
Eleven lots of ranitidine tablets, USP (150 mg) were recalled by American Health Packaging due to the potential to contain excess amounts of N-nitrosodimethylamine (NDMA), a probable carcinogen, the FDA reported on Feb. 27.
The recall was initiated in response to a separate recall by the manufacturer (Amneal Pharmaceuticals, LLC), which included affected lots that were repackaged by American Health Packaging. Recalled products were distributed nationwide to wholesalers for use in hospital settings.