Recalls / Class II
Class IID-0090-2024
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count 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 # HM03221A, Exp. date 12/31/2023
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
- 9,263 100-count bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2023-10-27
- FDA classified
- 2023-11-07
- Posted by FDA
- 2023-11-15
- Terminated
- 2025-08-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0090-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.