Drug product
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA
D-0423-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15885 bottles
- Official record key
drug-enforcement:D-0423-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 484241
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations