Drug product
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
D-0476-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1473 vials
- Official record key
drug-enforcement:D-0476-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 3410425
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations