← FDA ENFORCEMENT
D-0090-2024Class II

Amneal Pharmaceuticals of New York, LLC

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product type
Drug
Status
Terminated
Report date
2023-11-15
Distribution
Nationwide in the USA and Puerto Rico
Firm state
NY
Product quantity
9,263 100-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.