Drug product
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
D-0426-2024
Product summary
- Event
- Event 93976
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,452/100 count bottles
- Official record key
drug-enforcement:D-0426-2024
Official wording
Reason: Failed dissolution specifications
Code information: Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications