Why it was recalled
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Product description
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Lot numbers, UPCs & expiration codes
Lot # HL00721A, Exp. 12/2023
Where it was sold
LA, PA and OH.
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-0876-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 30, 2023
- FDA report date
- Jun 21, 2023
- Quantity
- 9,056 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0876-2023, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 92368
- Address
- 50 Horseblock Rd
- Code information
- Lot # HL00721A, Exp. 12/2023
- Postal code
- 11719-9509
- Report date
- Jun 21, 2023
- Product type
- Drugs
- Recall number
- D-0876-2023
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 9,056 bottles
- Termination date
- Jun 10, 2025
- Reason for recall
- Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
- Distribution pattern
- LA, PA and OH.
- Recall initiation date
- May 30, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2023