Approximately 393 vials of DOXOrubicin Hydrochloride Liposome Injection (doxorubicin), 20 mg/10 ml, have been recalled because of a lack of assurance of sterility. This means the manufacturer cannot guarantee the product is free from bacteria or other harmful microorganisms, which is critical for an injectable medication. The affected product is packaged in 10 mL single-use vials and was distributed nationwide in the United States. While no specific injuries or infections have been reported in the provided data, the company has notified customers by letter to address the potential risk.
If an injectable drug is not sterile, it can introduce contaminants directly into the patient's body, potentially leading to serious or life-threatening systemic infections, such as sepsis.
Drug recall 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 ยท Raw API Response
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