UPDATED 09/27/2013. FDA alerted patients and health care providers that budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. FDA observed a 1000 mL bottle of budesonide solution from The Compounding Shop that contained visible, white, floating material. FDA identified that material as a fungus and is concerned that contamination may be present in other budesonide solution products from The Compounding Shop that may currently be on the market.
FDA is alerting health care providers to immediately quarantine any budesonide solution products from The Compounding Shop, and not administer it to patients.
Read the Updated MedWatch Alert at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351326.htm.
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