Dr. Reddy’s Voluntarily Recalls Two Lots of Metoprolol SuccinateBy
Dr. Reddy’s Laboratories has initiated a Class II recall for two lots of metoprolol succinate extended-release tablets, USP 25 mg. 100-count bottle, prescription, only, manufactured by Dr. Reddy’s Laboratories Limited, Batchupally, India for failure of a dissolution test observed at the 18-month time point.
The company initiated the recall on May 23, 2014 for 13,560 bottles distributed nationwide. The affected lots were Lot # C206578 (expiration date of 05/14) and Lot # C207415 (expiration date of 06/14). FDA posted notice of the recall in its June 18, 2014 weekly Enforcement Report.
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.