Status
Terminated
Drug Enforcement D-0876-2023
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Classification
Class II
Report Date
June 21, 2023
Termination Date
June 10, 2025
Product Information
- 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.
- Product quantity
- 9,056 bottles
- Reason for recall
- Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- LA, PA and OH.
Location & Firm
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Address
-
50 Horseblock Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0876-2023
- Event ID
- 92368
- Recall initiation date
- May 30, 2023
- Center classification date
- June 15, 2023
- Code info
- Lot # HL00721A, Exp. 12/2023
- More code info
- —