Recalls / Class II
Class IID-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
- Brand name
- Divalproex Sodium
- Generic name
- Divalproex Sodium
- Active ingredient
- Divalproex Sodium
- Route
- Oral
- NDCs
- 65162-755, 65162-757
- FDA application
- ANDA203730
- Affected lot / code info
- 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
Why it was recalled
Failed dissolution specifications
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Manufacturer
- Amneal Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 21,452/100 count bottles
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2023-12-26
- FDA classified
- 2024-03-27
- Posted by FDA
- 2024-04-03
- Terminated
- 2024-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0426-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.