Glenmark Generics Recalls One Lot of RantidineBy
Glenmark Generics has issued a Class II voluntary recall of 2904 bottles of rantidine Tablets USP, 150 mg, 500-count bottles, prescription only, due to a pharmacist complaint of a “foreign material,” identified as a metoprolol tartrate tablet USP 50 mg, found co-mingled in a bottle of ranitidine tablets USP 150 mg, according to FDA’s Enforcement Report of April 16, 2013.
The company initiated the nationwide recall on March 18, 2014. It applies to one lot (Lot 12AN118A, Exp 10/14).
The product was manufactured by Shasun Pharmaceuticals Limited (Periyakalapet, Puducherry, India) for Glenmark Generics Inc, USA, Mahwah, New Jersey.
A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.