FDA recall D-0090-2024
Amneal Pharmaceuticals of New York, LLC · Class II · drug
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Reason for recall
Failed Dissolution Specifications
Distribution
Nationwide in the USA and Puerto Rico
Key facts
- Status
- Terminated
- Initiation date
- 2023-10-27
- Report date
- 2023-11-15
- Termination date
- 2025-08-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brookhaven, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0090-2024