Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Renaissance Lakewood, LLC

NDC code

33600-002-10

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0124-2018

Other Fluconazole recalls

See all

Class II · Moderate risk Terminated Dec 27, 2022

FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300…

Reason Lack of sterility assurance

Sentara Infusion Services D-0293-2023

Class III · Low risk Terminated Jul 11, 2018

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible…

Reason Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

Renaissance Lakewood, LLC D-1033-2018

Class III · Low risk Terminated Jul 11, 2018

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible…

Reason Failed Stability Specifications: lot out of specification for elevated water vapor.

Renaissance Lakewood, LLC NDC 36000-002-10 D-1032-2018

Class III · Low risk Terminated Jul 11, 2018

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible…

Reason Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

Renaissance Lakewood, LLC NDC 36000-003-06 D-1031-2018

Class II · Moderate risk Terminated Feb 21, 2018

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only…

Reason 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…

Renaissance Lakewood, LLC NDC 36000-002-10 D-0696-2018