Apollo Care is recalling 215 bags of Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride. This recall was initiated after suspected microbial growth was found on the external label packaging, which means the manufacturer cannot guarantee the medication is sterile. These prescription bags are intended for epidural use only and were distributed in Missouri.
If the sterility of a medication injected or administered via epidural is compromised, patients are at risk for serious infections. While the suspected growth was found on the external packaging, any lack of sterility assurance in a sterile drug product poses a significant health risk.
Product return and quarantine
Quantity affected: 215 bags
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.