Drug product
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.
D-1355-2014
Product summary
- Event
- Event 68402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8712 Bottles
- Official record key
drug-enforcement:D-1355-2014
Official wording
Reason: Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Code information: Lot #: LN11423, Expiry: 8/15/15
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications