The Recall Registry
Recall data checked 5 hours ago

Home Prescription medicine Genentech, Inc. — Cathflo activase (ALTEPLASE),…

Food & drug recall · FDAMay 20, 2024Serious

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

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Genentech, Inc.

The product

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

Details

Units affected
Lot:3618858 = 105,759; Lot:3618873 =90,359
Recall date
May 20, 2024
Brand
Genentech, Inc.
Model, lot or SKU numbers
Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Where it was distributed

Nationwide within the United States

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

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

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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