FDA recall D-0319-2024

Amneal Pharmaceuticals of New York, LLC · Class II · drug

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 for recall

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

Distribution

USA nationwide.

Key facts

Status: Terminated
Initiation date: 2024-01-15
Report date: 2024-02-14
Termination date: 2025-01-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0319-2024