Cathflo activase — Class II drug recall D-0509-2024
Terminated recall by Genentech, Inc., reported 2024-06-05, distributed nationwide. Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
| Recall number | D-0509-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech, Inc., South San Francisco, CA, United States |
| Recall initiated | 2024-05-20 |
| Classified | 2024-05-24 |
| Reported by FDA | 2024-06-05 |
| Terminated | 2025-08-11 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 50242-0041, 50242-0041-10, 50242-0041-64 |
| Lot numbers | 3618858, 3618873 |
| Expiration dates | 2026-01-31 |
Product
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Reason for recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0509-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.