Phenoxybenzamine Hydrochloride Capsules recall: Impurity Out of Spec
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
Why was Phenoxybenzamine Hydrochloride Capsules recalled?
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
- 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
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Quantity
- 858 bottles
- Distribution
- USA nationwide.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)