Drug product
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
D-0327-2024
Product summary
- Event
- Event 93959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46,037 Bottles
- Official record key
drug-enforcement:D-0327-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification test results.
Code information: Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification