FDA-Drug2024-02-14Class II
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
Amneal Pharmaceuticals of New York, LLC
Hazard
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Sold states
USA nationwide.
Affected count
858 bottles
Manufactured in
50 Horseblock Rd, Brookhaven, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0319-2024Don't want to check this manually?
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