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Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, ...

FDA Recall #D-0509-2024 — Class II — May 20, 2024

Recall #D-0509-2024 Date: May 20, 2024 Classification: Class II Status: Terminated

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.

Recalling Firm

Genentech, Inc. — South San Francisco, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

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

Distribution

Nationwide within the United States

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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