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Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.
On March 1, 2016, Sagent Pharmaceuticals announced that it was recalling 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. The recall is in response to the discovery of an out of specification impurity result detected during routine quality testing of stability samples at the 18-month interval, which was identified as Metronidazole. The recalled lot, Lot 40608, was distributed to hospitals, wholesalers, and distributors nationwide from November 2014–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. According to the company, an elevated impurity has the potential to decrease effectiveness of the product in patients. As of March 1, Sagent has not received any reports of adverse patient events.
The company has instructed customers to examine their inventory immediately and to quarantine and discontinue distribution of the recalled lot. Adverse events should be reported to FDA’s MedWatch Adverse Event Reporting program.