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

Recall Number: D-0319-2024

Firm: Amneal Pharmaceuticals of New York, LLC

Classification: Class II

Status: Terminated

Report Date: 20240214

Initiation Date: 20240115

Termination Date: 20250131

Reason for Recall

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

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