Cathflo activase recalled over sterility concerns
- Recall date
- May 20, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Genentech, Inc. recalls Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Recall number
- D-0509-2024
- FDA classification
- Class II
- Brand / firm
- Genentech, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
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