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.
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.
Recall #: D-0509-2024
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.
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.