Wockhardt Usa Inc. recalls Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 40
Recalled December 24, 2014 · FDA recall D-0304-2015 · Wockhardt Usa
Hazard
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point. · FDA Class III
Units
1,118,400 extended release tablets
Sold at
Nationwide.
Description
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Product
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 .
Manufacturer(s)
Wockhardt Usa Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →