Drug product
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
D-1135-2015
Product summary
- Event
- Event 71374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 count 7479; 500 count - 2544
- Official record key
drug-enforcement:D-1135-2015
Official wording
Reason: Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Code information: 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications