Amneal Pharmaceuticals of New York, LLC: Drug Recall
Recall #D-0319-2024 · 01/15/2024
Class II: Risk
Recall Details
- Recall Number
- D-0319-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Status
- Terminated
- Date Initiated
- 01/15/2024
- Location
- Brookhaven, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 858 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
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
Distribution Pattern
USA nationwide.
Other Recalls by Amneal Pharmaceuticals of New York, LLC
- Class II: Risk 03/25/2024
- Class I: Dangerous 03/21/2024
- Class II: Risk 02/13/2024
- Class II: Risk 12/26/2023
- Class II: Risk 10/27/2023
View all recalls by Amneal Pharmaceuticals of New York, LLC →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.