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
Reported: February 14, 2024 Initiated: January 15, 2024 #D-0319-2024
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Units Affected
- 858 bottles
- Distribution
- USA nationwide.
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 858 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2024. Severity: Moderate. Recall number: D-0319-2024.
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