Class II Recall

Amneal Pharmaceuticals of New York, LLC

Product
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
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Classification
Class II
Status
Terminated
Lot
Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.