Class III
Terminated
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 .
- Company
- Wockhardt Usa Inc.
- Recall Initiated
- April 17, 2014
- Posted
- December 24, 2014
- Recall Number
- D-0304-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,118,400 extended release tablets
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Distribution
Nationwide.
Lot / Code Info
a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
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