Sagent Pharmaceuticals, Inc., is recalling one lot of Fluconazole injection used to treat oropharyngeal and esophageal candidiasis, cryptococcal meningitis, due to an impurity that can decrease the effectiveness of the product in patients. The impurity was identified as the antibiotic Metronidazole, and patients treated with this product who are already taking Metronidazole may receive an increased dose of the drug.
Metronidazole is used to treat various infections, including certain types of vaginal infections. It can also treat skin redness and pimples caused by rosacea. The issue was identified during routine quality testing of stability samples at the 18-month interval.
The recall involves Fluconazole injection in 0.9% Sodium Chloride, 200 mg per 100mL flexible container bag (NDC 25021-113-882) Lot 40608, which is manufactured by ACS Dobfar INFO S.A. and distributed by Sagent. The affected lot was distributed to hospitals, wholesalers and distributors nationwide from November 2014 through December 2014.
Sagent is notifying distributors by fax, email, FedEx and/or certified mail and providing information regarding the return of all recalled products. Distributors have also been instructed to examine their inventory and immediate quarantine, discontinue distribution and return any products from the recalled lot. They have also been asked to notify any customers who have received the product and inform them of the recall.
Sagent is not aware of any adverse events in patients receiving Fluconazole. Anyone treated with this medication and has experienced any side effects should contact their physician. Adverse events should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.