Antifungal Injection Recalled

January 9, 2017

Baxter Healthcare Corporation is voluntarily recalling more than 30,000 bags Fluconazole Injection, USP, 200 mg/100 mL, from US, United Arab Emirates, and Columbian markets.


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Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus, abdomen, lungs, blood, and other organs. It may also be used to treat meningitis caused by fungus as well as to prevent potential yeast infections in patients receiving chemotherapy or radiation therapy before bone marrow transplant.

According to a Drug Enforcement Report released by the US Food and Drug Administration, the drug was recalled due to a lack of assurance of sterility after customer complaints of leaking bags were confirmed. It was designated a class II recall on December 19, 2016, meaning that exposure to the drug could cause temporary or medically reversible adverse health consequences with a remote possibility of serious consequences or death.

The recall is currently on going for lot number P344028 on bags, P344028A on shipping container.


Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 28, 2016. Accessed January 6, 2017.

Fluconazole Injection. US National Library of Medicine Website. http://bit.ly/2ivwGzq. Updated December 15, 2015. Accessed January 9, 2017.