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