Drug Enforcement D-0090-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class II

Report Date

November 15, 2023

Termination Date

August 6, 2025

Product Information

Product description
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Product quantity
9,263 100-count bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Puerto Rico

Location & Firm

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Address
50 Horseblock Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0090-2024
Event ID
93292
Recall initiation date
October 27, 2023
Center classification date
November 7, 2023
Code info
Lot # HM03221A, Exp. date 12/31/2023
More code info
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