FDA Drug Class II — Moderate

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

Hazard

Failed Dissolution Specifications

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Products

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Brand
Amneal Pharmaceuticals of New York, LLC
UPC
Lot # HM03221A, Exp. date 12/31/2023

Units Affected

9,263 100-count bottles

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