SCA Pharmaceuticals has recalled 2,125 units of Fentanyl 1,500 mcg/30 mL syringes (50 mcg/mL concentration) because the drug was found to be subpotent. This means the syringes do not contain the full labeled dose of medication, which can lead to inadequate pain management for patients. The affected syringes are preservative-free, prescription-only, single-dose containers used for intravenous injection in clinical settings. No injuries or incidents have been reported to date.
The drug is subpotent, meaning it provides less fentanyl than intended. Patients receiving this medication may experience insufficient pain relief, potentially requiring additional dosing and complicating clinical treatment.
Manufactured in Windsor, CT 06095.
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.