Amneal Pharmaceuticals of New York, LLC recalls Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals P…

Recall date

January 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0319-2024

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

USA nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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