Class II · Moderate risk
Sufenta (Sufentanil Citrate Injection, USP)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
SUFENTANIL 150MCG/ML INJ in 20 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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drug: Sufentanil
- Recalling firm
- Assurance Infusion
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0767-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sufentanil recalls
See all
Class II · Moderate risk
Sufentanil Citrate Injection
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class I · High risk
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Non-Sterility
Class I · High risk
Class II · Moderate risk
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion
Lack of sterility assurance.
Other recalls by Assurance Infusion
All 2019 recalls
Class II · Moderate risk
Trimix Super
Lack of sterility assurance.
Class II · Moderate risk
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Trimix Forte 4
Lack of sterility assurance.
Class II · Moderate risk
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion
Lack of sterility assurance.
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