PlainRecalls
FDA Drug Moderate Class II Terminated

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA

Reported: August 27, 2014 Initiated: July 24, 2014 #D-1541-2014

Product Description

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA

Reason for Recall

Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.

Details

Recalling Firm
Wockhardt Usa Inc.
Units Affected
11,661 HDPE bottles
Distribution
Nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA. Recalled by Wockhardt Usa Inc.. Units affected: 11,661 HDPE bottles.
Why was this product recalled?
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 27, 2014. Severity: Moderate. Recall number: D-1541-2014.