Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceutical
Recalled June 21, 2023 · FDA recall D-0876-2023 · Amneal Pharmaceuticals of New York
Hazard
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) · FDA Class II
Units
9,056 bottles
Sold at
LA, PA and OH.
Description
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
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.
Manufacturer(s)
Amneal Pharmaceuticals of New York, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →