Home / Recalls / Genentech, Inc. / D-0509-2024

D-0509-2024 Class II Terminated

Recalled by Genentech, Inc. — South San Francisco, CA

FDA drug recall D-0509-2024 was initiated by Genentech, Inc. on May 20, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. The recall status is terminated (terminated Aug 11, 2025). Affected quantity: Lot:3618858 = 105,759; Lot:3618873 =90,359.

Recall Details

Product Type: Drugs
Report Date: Jun 5, 2024
Initiation Date: May 20, 2024
Termination Date: Aug 11, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Lot:3618858 = 105,759; Lot:3618873 =90,359

Product Description

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 3618858, 3618873, Exp. Date 01/31/2026

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0509-2024
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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