AUDIENCE: Infectious Disease, Pharmacy, Nursing
ISSUE: Sagent has initiated a voluntary recall of one lot 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.
BACKGROUND: 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.
RECOMMENDATION: Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/05/2016 - Press Release – Sagent Pharmaceuticals, Inc.]