Drug recall D-0426-2024
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
Reason for recall
Failed dissolution specifications
Lots and codes
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
Recall details
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY
- Quantity
- 21,452/100 count bottles
- Distribution
- Product was distributed nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 26, 2023
- Terminated
- August 16, 2024
Related products
- Divalproex Sodium – drug information
- NDC 65162-757 Divalproex Sodium · Divalproex Sodium 500 mg/1 · Amneal Pharmaceuticals LLC
- NDC 65162-755 Divalproex Sodium · Divalproex Sodium 250 mg/1 · Amneal Pharmaceuticals LLC