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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cathflo Activase Recalled for Potential Lack of Sterility

Agency Publication Date: May 24, 2024
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Summary

Genentech, Inc. has recalled 3,618,858 units of Cathflo Activase (alteplase) 2mg vials due to a potential lack of assurance of sterility. Deformed stoppers were observed during filling operations, which could compromise the sterile barrier of the injectable medication. Consumers should contact their healthcare provider or pharmacist if they have concerns, though the product is typically administered in a clinical setting.

Risk

The use of a non-sterile injectable medication can lead to serious, potentially life-threatening infections. No injuries or adverse events have been reported to date regarding this defect.

What You Should Do

  1. The recalled products are Cathflo Activase (alteplase) 2mg vials (NDC 50242-041-64) from lots 3618858 and 3618873, both with an expiration date of January 31, 2026.
  2. Stop using the recalled product immediately. Contact Genentech, Inc. or your distributor to arrange for the return of any remaining vials from the affected lots.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information about this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Cathflo Activase (alteplase), 2mg vials
Variants: 2mg vial
Lot Numbers:
3618858 (Exp 01/31/2026)
3618873 (Exp 01/31/2026)
NDC:
50242-041-64

Recall #: D-0509-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94653
Status: Resolved
Manufacturer: Genentech, Inc.
Sold By: Wholesalers; Distributors; Hospitals; Infusion Centers
Manufactured In: United States
Units Affected: Lot:3618858 = 105,759; Lot:3618873 =90,359
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.