Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
Recall Number: D-0304-2015
Firm: Wockhardt Usa Inc.
Classification: Class III
Status: Terminated
Report Date: 20141224
Initiation Date: 20140417
Termination Date: 20150813
Reason for Recall
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Product Description
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .