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FDA issues safety alert for fluconazole injection
The FDA released a safety announcement alerting health care professionals and patients of a voluntary recall on one lot of fluconazole injection, USP (in 0.9% sodium chloride), 200 mg/100 mL, after routine testing of stability samples yielded impurity results at the 18-month interval.
The FDA specified that the impurity — which could reduce the effectiveness of the product — was identified as metronidazole. Patients receiving the fluconazole injection and concomitant medication containing metronidazole may have received an increased dose.
Lot number 40608 has been recalled; it was distributed nationwide to hospitals, wholesalers and distributors from November 2014 to December 2014, the FDA said. The product is used for the treatment of oropharyngeal candidiasis, esophageal candidiasis and cryptococcal meningitis.
Sagent, the product’s manufacturer, has not received reports of adverse patient events related to the use of the injection, according to a press release. The FDA urges health care professionals and patients to report any adverse events to its MedWatch Safety Information and Adverse Event Reporting Program.
For more information: MedWatch Online Voluntary Reporting Form