SSM Health Care St. Louis is recalling Phenylephrine HCl (1,000 mcg/10 mL) syringes and Fentanyl citrate (10 mcg/mL) vials used for intravenous hospital administration. Approximately 11,938 units are affected because the manufacturer did not validate the sterilization process, which means there is no assurance the drugs are actually sterile. These medications are compounded drugs intended for hospital and office use only and were distributed in Missouri.
A lack of assurance of sterility poses a serious risk to patients because contaminated intravenous medications can cause life-threatening infections. No specific injuries or illnesses have been reported to date regarding these specific lots.
Recall #: D-0435-2024. Quantity: 11,798 syringes.
Recall #: D-0436-2024. Quantity: 140 vials.
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.