Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
Recall Number: D-1300-2014
Firm: Wockhardt Usa Inc.
Classification: Class II
Status: Terminated
Report Date: 20140514
Initiation Date: 20140401
Termination Date: 20150512
Reason for Recall
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Product Description
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.