Home / Recalls / Amneal Pharmaceuticals of New York, LLC / D-0090-2024

D-0090-2024 Class II Terminated

Recalled by Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY

Recall Details

Product Type: Drugs
Report Date: November 15, 2023
Initiation Date: October 27, 2023
Termination Date: August 6, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,263 100-count bottles

Product Description

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 Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot # HM03221A, Exp. date 12/31/2023

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