FDA Drug recall D-0509-2024
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- FDA Drug
- Class II
- terminated
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64 by Genentech, citing lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0509-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-05-20 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Genentech |
| Distribution | US |
Product
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Reason
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Identifiers
| ndc | 50242-041-64 |
|---|---|
| ndc | 50242-041-10 |
| code_info | Lot #: 3618858, 3618873, Exp. Date 01/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0509-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.