Home / Recalls / Amneal Pharmaceuticals of New York, LLC / D-0319-2024

D-0319-2024 Class II Terminated

Recalled by Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY

Recall Details

Product Type
Drugs
Report Date
February 14, 2024
Initiation Date
January 15, 2024
Termination Date
January 31, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
858 bottles

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

Reason for Recall

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

Distribution Pattern

USA nationwide.

Code Information

Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025

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