OSELTAMIVIR PHOSPHATE Recall D-0327-2024
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
OSELTAMIVIR PHOSPHATE Recall D-0327-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0327-2024 |
| Event ID | 93959 |
| Brand | OSELTAMIVIR PHOSPHATE |
| Generic Name | OSELTAMIVIR PHOSPHATE |
| Manufacturer | OSELTAMIVIR PHOSPHATE |
| Original Package? | 1 |
| Active Substance | OSELTAMIVIR PHOSPHATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 46,037 Bottles |
| Recall Reason | Failed Impurities/Degradation Specifications: Out-of-specification test results. |
| Drug Classification | Class II |
| Drug Code Info | 20240228 |
| Product NDC | 69238-1273 |
| Drug UPC | 0369238127362 |
| Recall Initiation Date | 20240213 |
| Report Date | 20240228 |
| Classification Date | 20240216 |
| Address | 50 Horseblock Rd Brookhaven, NY 11719-9509 United States |
| Recalling Firm | Amneal Pharmaceuticals of New York, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4A3O49NGEZ |
| Drug Application Number | ANDA210186 |
| Structured Product Labeling (SPL ID) | 7555923d-e9a7-4472-8acc-f90061f8cc5d |
| Structured Product Labeling (SPL Set ID) | c1a280d0-4ce9-494a-9924-eb5621ce3757 |
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