Why it was recalled
Failed dissolution specifications.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: AR210705, Exp 04/2024
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1362-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2022
- FDA report date
- Aug 31, 2022
- Quantity
- 4,309 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-1362-2022, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 90680
- Address
- 50 Horseblock Rd
- Code information
- Lot #: AR210705, Exp 04/2024
- Postal code
- 11719-9509
- Report date
- Aug 31, 2022
- Product type
- Drugs
- Recall number
- D-1362-2022
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 4,309 bottles
- Termination date
- Aug 17, 2023
- Reason for recall
- Failed dissolution specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide
- Recall initiation date
- Jul 27, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2022