Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Non-Sterility
Reason Non-Sterility
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
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