Drug product
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
D-0509-2024
Product summary
- Firm
- Genentech, Inc.
- Event
- Event 94653
- Status
- Terminated
- Classification
- Class II
- Quantity
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Official record key
drug-enforcement:D-0509-2024
Official wording
Reason: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Code information: Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility