Class III · Low risk
Fluconazole Injection
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Fluconazole 200mg Ns 100ml
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
FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Drug: Fluconazole
- Recalling firm
- Sentara Infusion Services
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0293-2023 · 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 Fluconazole recalls
See all
Class III · Low risk
Fluconazole Injection
Failed Stability Specifications: lot out of specification for elevated water vapor.
Class III · Low risk
Fluconazole Injection
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Class II · Moderate risk
Fluconazole Injection
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Class II · Moderate risk
Fluconazole USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Other recalls by Sentara Infusion Services
All 2022 recalls
Class II · Moderate risk
VITAMIN K (Phytonadione)
Lack of sterility assurance
Class II · Moderate risk
Vancomycin
Lack of sterility assurance
Class II · Moderate risk
Vancomycin
Lack of sterility assurance
Class II · Moderate risk
TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM…
Lack of sterility assurance
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