Class II · Moderate risk Ongoing
Sufenta
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Sufentanil 50 mcg/ml Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What was recalled
Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Recalling firm
- The Compounding Pharmacy of America
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1637-2015
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 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
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