Drug product
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
D-1362-2022
Product summary
- Event
- Event 90680
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,309 bottles
- Official record key
drug-enforcement:D-1362-2022
Official wording
Reason: Failed dissolution specifications.
Code information: Lot #: AR210705, Exp 04/2024
Distribution pattern: USA nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications