Class II · Moderate risk Ongoing
Sufenta
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800
- Recalling firm
- Assurance Infusion
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0769-2020
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.
Other Sufentanil recalls
See all
Class II · Moderate risk Terminated
Sufentanil Citrate Injection
Reason Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class I · High risk Terminated
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Reason Non-Sterility
Class I · High risk Terminated
Sufentanil-Bupivacaine-Baclofen Pf 25mcg-12.5mg-750mcg/Ml…
Reason Non-Sterility
Class II · Moderate risk Terminated
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
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