Qualgen, LLC has voluntarily recalled several lots of its Estradiol and Testosterone pellet implants, which are prescription hormone replacement therapies. These products are being recalled due to a lack of assurance of sterility, meaning the company cannot guarantee the pellets are free from microorganisms like bacteria or fungi. Consumers who have had these pellets implanted should monitor for signs of infection at the injection site and consult their healthcare provider.
A lack of assurance of sterility in an implanted medication can lead to serious infections at the site of the procedure or throughout the body. While no specific injuries have been reported in this data, non-sterile injectable products pose a significant health risk to patients.
Healthcare guidance and product refund
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.