Genentech, Inc.: Drug Recall

Recall #D-0509-2024 · 05/20/2024

Class II: Risk

Recall Details

Recall Number: D-0509-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Genentech, Inc.
Status: Terminated
Date Initiated: 05/20/2024
Location: South San Francisco, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Lot:3618858 = 105,759; Lot:3618873 =90,359

Reason for Recall

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

Product Description

Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

Distribution Pattern

Nationwide within the United States

Other Recalls by Genentech, Inc.

Class III: Low Risk 10/18/2022

Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class II: Risk 06/09/2021

Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class III: Low Risk 04/20/2021

Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.

View all recalls by Genentech, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.