FDAFDA · Food and drugs·Recall number D-0319-2024
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
Published February 14, 2024 · Recall initiated: January 15, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- USA nationwide.
- Lot
- Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.