Recalls / Class II
Class IID-0319-2024
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
- Affected lot / code info
- Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 858 bottles
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-01-15
- FDA classified
- 2024-02-08
- Posted by FDA
- 2024-02-14
- Terminated
- 2025-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0319-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.