Drug product
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
D-1136-2015
Product summary
- Event
- Event 71374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,160 bottles
- Official record key
drug-enforcement:D-1136-2015
Official wording
Reason: Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Code information: Lot #C308195, exp 10/2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications