NDC 50242-041
Cathflo Activase 2.2 mg per 2 mL injection, powder, lyophilized, for solution
On the label: Genentech, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Genentech, Inc. | Hillsboro, OR, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 19, 2024 · 7 inspections |
| Genentech, Inc. | Oceanside, CA, United States | Tests it | No problems foundAug 16, 2024 · 5 inspections |
Recalls
- May 20, 2024 · Class II · Genentech, Inc.
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Lots: Lot #: 3618858, 3618873, Exp. Date 01/31/2026 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 3410425
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Alteplase: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 2.2 mg per 2 mL
- Approval
- BLA BLA103172
- On the market since
- Sep 4, 2001
- Package NDCs
50242-041-1050242-041-64- Official label
- DailyMed (National Library of Medicine), updated Jan 20, 2026
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