Drug recall
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC…
FDA recall event 94653 · Class II · Genentech, Inc.
Key facts
| Event ID | 94653 |
|---|---|
| Recall numbers | D-0509-2024 |
| Recalling firm | Genentech, Inc. |
| Product type | Drugs |
| Products | Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. |
| Initiation date | May 20, 2024 |
| Report date | Jun 5, 2024 |
| Termination date | Aug 11, 2025 |
| City | South San Francisco |
| State | CA |
| Country | United States |
| FEI number | 2917293 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: