Drug product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
D-1300-2014
Product summary
- Event
- Event 67933
- Status
- Terminated
- Classification
- Class II
- Quantity
- 109,744 bottles
- Official record key
drug-enforcement:D-1300-2014
Official wording
Reason: Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Code information: Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications