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# Sagent Recalls Fluconazole Injection Due to Impurity
- URL: https://www.fdaweb.com/sagent-recalls-fluconazole-injection-due-to-impurity/
- Published: 2016-03-07T12:00:00.000Z
- Updated: 2026-09-15T02:41:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134980

> Sagent has recalled one lot of fluconazole injection, USP, 200mg per 100mL to the user level due to an out of specification impurity result detected during routine quality testing of stability samples at its 18-month interval. This impurity has been identified as metronidazole, according to a [recall notice](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm489316.htm?ref=fdaweb.com), and such an elevated impurity “has the potential to decrease effectiveness of the product in patients. Fluconazole injection is indicated for treating of oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and is supplied in 100mL and 200mL flexible container bags.