Recalls / Class II
Class IID-0476-2021
Product
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
- Brand name
- Cathflo Activase
- Generic name
- Alteplase
- Active ingredient
- Alteplase
- Route
- Intravenous
- NDC
- 50242-041
- FDA application
- BLA103172
- Affected lot / code info
- 3410425
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 1473 vials
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0476-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.