Class II
Terminated
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
- Recall Initiated
- January 15, 2024
- Posted
- February 14, 2024
- Recall Number
- D-0319-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 858 bottles
- Firm Location
- Brookhaven, NY, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Distribution
USA nationwide.
Lot / Code Info
Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
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