Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of sterility assurance.
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800
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 Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Reason Non-Sterility
Reason Non-Sterility
Reason Lack of sterility assurance.
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