Drug 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 .
D-0304-2015
Product summary
- Event
- Event 69506
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,118,400 extended release tablets
- Official record key
drug-enforcement:D-0304-2015
Official wording
Reason: Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Code information: a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
out of specification