Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater
Recalled November 15, 2023 · FDA recall D-0090-2024 · Amneal Pharmaceuticals of New York
Hazard
Failed Dissolution Specifications · FDA Class II
Units
9,263 100-count bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Dissolution Specifications
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Manufacturer(s)
Amneal Pharmaceuticals of New York, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →