Class II

Drug Recall: 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

Amneal Pharmaceuticals of New York, LLC · January 15, 2024

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

Distribution

USA nationwide.

States Affected

NATIONWIDE

Quantity Affected

858 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0319-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.