Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

Recall Number: D-0090-2024

Firm: Amneal Pharmaceuticals of New York, LLC

Classification: Class II

Status: Terminated

Report Date: 20231115

Initiation Date: 20231027

Termination Date: 20250806

Reason for Recall

Failed Dissolution Specifications

Product Description

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10