ALTEPLASE Recall D-0509-2024
Description: Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
ALTEPLASE Recall D-0509-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0509-2024 |
| Event ID | 94653 |
| Brand | CATHFLO ACTIVASE |
| Generic Name | ALTEPLASE |
| Manufacturer | ALTEPLASE |
| Original Package? | 1 |
| Active Substance | ALTEPLASE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States |
| Quantity | Lot:3618858 = 105,759; Lot:3618873 =90,359 |
| Recall Reason | Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. |
| Drug Classification | Class II |
| Drug Code Info | 20240605 |
| Product NDC | 50242-041 |
| Recall Initiation Date | 20240520 |
| Report Date | 20240605 |
| Classification Date | 20240524 |
| Address | 1 Dna Way Bldg 5 South San Francisco, CA 94080-4918 United States |
| Recalling Firm | Genentech, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 1RXS4UE564 |
| Drug Application Number | BLA103172 |
| Structured Product Labeling (SPL ID) | 7595e1d4-9e6f-4887-b051-efd6c7b0e058 |
| Structured Product Labeling (SPL Set ID) | 91ecdef2-95ff-42dd-a31c-c8a09cab3ad9 |
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