Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg Per 100mL Due to the Discovery of an Out of Specification Impurity

Sagent Pharmaceuticals, Inc.

today announced the voluntary nationwide recall of one lot of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100mL flexible container bag (NDC 25021-113-82) Lot 40608 manufactured by ACS Dobfar INFO S.A. and distributed by Sagent. Sagent has initiated this voluntary recall of Fluconazole Injection, USP, 200mg per 100mL to the user level due to the discovery of an out of specification impurity result detected during routine quality testing of stability samples at the 18-month interval. This impurity has been identified as Metronidazole. An elevated impurity has the potential to decrease effectiveness of the product in patients. Patients on the product and on concomitant medication of Metronidazole may receive an increased dose of Metronidazole. Sagent is not aware of any adverse patient events resulting from the use of the subject product lot. The lot number being recalled is Lot 40608 which was distributed to hospitals, wholesalers and distributors nationwide from November 2014 through December 2014. Fluconazole Injection, USP, 200mg per 100mL is indicated, for the treatment of Oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and is supplied in 100mL and 200mL flexible container bags.