Drug product
GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
D-0432-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 CARTON
- Official record key
drug-enforcement:D-0432-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 7T10050A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations