Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmace...
FDA Recall #D-0090-2024 — Class II — October 27, 2023
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
Recalling Firm
Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9,263 100-count bottles
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot # HM03221A, Exp. date 12/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated