Class II · Moderate risk
Fluconazole 200mg Ns 100ml
Lack of sterility assurance
Fluconazole Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Cross contamination with other products: metronidazole
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
Affected NDC
25021-0113-82
Compare with the code on your package — it is the most precise check available.
Drug: Fluconazole
- Recalling firm
- Sagent Pharmaceuticals Inc
- NDC code
- 25021-0113-82
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0780-2016 · 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
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
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.
Other recalls by Sagent Pharmaceuticals Inc
All 2016 recalls
Class III · Low risk
Busulfan Injection
Failed Impurities/Degradation Specifications
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
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