Class IITerminated

Cathflo activase (ALTEPLASE) recall

FDA recall D-0509-2024 · initiated May 20, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Recalling company: Genentech Inc
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: May 20, 2024
FDA report date: Jun 5, 2024

This recall is linked to a product we cover: Cathflo Activase →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0509-2024 ↗

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