Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cathflo activase (ALTEPLASE) Recalled by Genentech, Inc. Due to Lack of Assurance of Sterility: Deformed stoppers observed...

Date: May 20, 2024
Company: Genentech, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Genentech, Inc. directly.

Affected Products

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

Quantity: Lot:3618858 = 105,759; Lot:3618873 =90,359

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Genentech, Inc.

Genentech, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report