Recalls / Class II
Class IID-0876-2023
Product
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.
- Brand name
- Extended Phenytoin Sodium
- Generic name
- Phenytoin Sodium
- Active ingredient
- Phenytoin Sodium
- Route
- Oral
- NDC
- 65162-212
- FDA application
- ANDA040765
- Affected lot / code info
- Lot # HL00721A, Exp. 12/2023
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
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
- 9,056 bottles
- Distribution pattern
- LA, PA and OH.
Timeline
- Recall initiated
- 2023-05-30
- FDA classified
- 2023-06-15
- Posted by FDA
- 2023-06-21
- Terminated
- 2025-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0876-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.