Sanofi-Aventis U.S. LLC has voluntarily recalled 7,451 vials of Elitek (rasburicase) for injection, 7.5 mg. The recall was initiated because routine testing showed that certain vials did not meet the required enzyme activity levels, meaning the medication may not be as effective as expected. This prescription drug is used to manage uric acid levels in patients receiving certain cancer treatments. Consumers who have this medication should not use the affected lot and should contact their healthcare provider immediately.
The reduced enzyme activity levels mean the drug may not effectively lower uric acid levels in the blood, which can lead to serious complications for patients undergoing chemotherapy. While no specific injuries were reported in this notice, the failure to meet stability specifications could compromise the therapeutic benefit of the injection.
Contact healthcare provider or pharmacist for refund/guidance.
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 · 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.