Drug product
CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL
D-0595-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 boxes
- Official record key
drug-enforcement:D-0595-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 303824
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations