FDAFDA · Food and drugs·Recall number D-0509-2024
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Published June 5, 2024 · Recall initiated: May 20, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CATHFLO ACTIVASE
- Manufacturer
- Genentech, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 3618858, 3618873, Exp. Date 01/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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