Drug product
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
D-1541-2014
Product summary
- Event
- Event 68941
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,661 HDPE bottles
- Official record key
drug-enforcement:D-1541-2014
Official wording
Reason: Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Code information: Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications