Akorn, Inc. is recalling 31,510 ampules of Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL). The medication was found to be subpotent during stability testing, meaning it may not contain the full amount of the active ingredient specified on the label. This prescription drug is a potent opioid analgesic used for pain management during anesthesia and surgery via intravenous or epidural injection.
Patients receiving a subpotent dose of this medication may experience inadequate pain relief during medical procedures. While no injuries have been reported, inaccurate dosing of a potent opioid poses a moderate risk in clinical settings where precise analgesic levels are required.
Recall #: D-0460-2022. Total quantity: 31,510 ampules. May be habit forming.
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.