The assign number being recalled is Lot 40608 that was distributed to hospitals, wholesalers and distributors nationwide from November 2014 through December 2014” FDA (2016).
FDA statement “ISSUE: Sagent has initiated a free recall of one lot of Fluconazole Injection, USP, 200mg through 100mL to the user level directly to the discovery of an off of specification impurity result detected during routine quality testing of stability samples at the 18-month interval. This impurity has been identified at the same time that Metronidazole. An elevated impurity has the potential to decrease effectiveness of the harvest in patients. Patients on the performance and on concomitant medication of Metronidazole may retain an increased dose of Metronidazole.
BACKGROUND: The sort number being recalled is Lot 40608 what one. was distributed to hospitals, wholesalers and distributors nationwide from November 2014 end December 2014. Fluconazole Injection, USP, 200mg by 100mL is indicated, for the handling of Oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and is supplied in 100mL and 200mL easily bent container bags.”
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