Recalls / Class II
Class IID-0509-2024
Product
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Brand name
- Cathflo Activase
- Generic name
- Alteplase
- Active ingredient
- Alteplase
- Route
- Intravenous
- NDC
- 50242-041
- FDA application
- BLA103172
- Affected lot / code info
- Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Why it was recalled
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Recalling firm
- Firm
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Dna Way Bldg 5, South San Francisco, California 94080-4918
Distribution
- Quantity
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-20
- FDA classified
- 2024-05-24
- Posted by FDA
- 2024-06-05
- Terminated
- 2025-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0509-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.