Prescription drug
Where is Alteplase made?
1 company sell it under their own name. Their labels name 1 factory in the United States.
United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Genentech, Inc. Activase, Cathflo Activase2.2 mg per 2 mL, 50 mg per 50 mL, 100 mg per 100 mL · NDC 50242-085, 50242-041, 50242-044 | Genentech, Inc.Makes it, tests it, packages it and labels it | Hillsboro, OR, United States | Problems found, fixed voluntarilyApr 2024 |
Recalls
- May 20, 2024 · Class II · Genentech, Inc.
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.