Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Am...
FDA Recall #D-0319-2024 — Class II — January 15, 2024
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.
Recalling Firm
Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
858 bottles
Distribution
USA nationwide.
Code Information
Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated