PlainRecalls
FDA Drug Moderate Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.

Reported: June 4, 2014 Initiated: April 10, 2014 #D-1355-2014

Product Description

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.

Reason for Recall

Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.

Details

Recalling Firm
Wockhardt Usa Inc.
Units Affected
8712 Bottles
Distribution
Nationwide.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.. Recalled by Wockhardt Usa Inc.. Units affected: 8712 Bottles.
Why was this product recalled?
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 4, 2014. Severity: Moderate. Recall number: D-1355-2014.