Class II · Moderate risk
Fluconazole 200mg Ns 100ml
Lack of sterility assurance
Fluconazole Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
Affected NDC
36000-0003-06
Compare with the code on your package — it is the most precise check available.
Drug: Fluconazole
- Recalling firm
- Renaissance Lakewood, LLC
- NDC code
- 36000-003-06
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1031-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 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 Renaissance Lakewood, LLC
All 2018 recalls
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
Flucanazole Injection
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
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.
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