Drug Enforcement D-0319-2024

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Status

Terminated

Classification

Class II

Report Date

February 14, 2024

Termination Date

January 31, 2025

Product Information

Product description
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
Product quantity
858 bottles
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

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-0319-2024
Event ID
93813
Recall initiation date
January 15, 2024
Center classification date
February 8, 2024
Code info
Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
More code info
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