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
D-0319-2024
Product summary
- Event
- Event 93813
- Status
- Terminated
- Classification
- Class II
- Quantity
- 858 bottles
- Official record key
drug-enforcement:D-0319-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Code information: Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Out of specification