Recalls / Class II
Class IID-1362-2022
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
- 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 #: AR210705, Exp 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, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 4,309 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2022-07-27
- FDA classified
- 2022-08-19
- Posted by FDA
- 2022-08-31
- Terminated
- 2023-08-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1362-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.