D-0327-2024 Class II Terminated
FDA drug recall D-0327-2024 was initiated by Amneal Pharmaceuticals of New York, LLC on February 13, 2024 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out-of-specification test results. The recall status is terminated (terminated February 14, 2025). Affected quantity: 46,037 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 28, 2024
- Initiation Date
- February 13, 2024
- Termination Date
- February 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,037 Bottles
Product Description
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024