Sagent announced a voluntary recall of 1 lot of Fluconazole Injection, USP, 200mg/100mL due to the discovery of an out of specification impurity result detected during routing quality testing of stability samples at the 18-month interval.
The impurity has been confirmed as metronidazole. An increased level of impurity can potentially decrease the efficacy of the drug. Patients who are taking concomitant metronidazole may receive an increased dose of metronidazole.
Fluconazole Injection is an azole antifungal indicated for the treatment of oropharyngeal and esophageal candidiasis and cryptococcal meningitis. The recalled product has Lot #40608 and was distributed nationwide from November 2014–December 2014. It is supplied in 100mL and 200mL flexible container bags.
Those with the affected inventory are to quarantine, discontinue distribution, and return the recalled lot.
For more information call (866) 625-1618 or visit FDA.gov.