FDA Provides New Information About Lack of Sterility Assurance for Drugs Dispensed by The Compounding Shop

October 2, 2013 5:30 PM

Food and Drug Administration (FDA) is warning patients and health care providers that budesonide solution (for nasal irrigation), dispensed by The Compounding Shop of St Petersburg, FL, may be contaminated and should not be used or administered to patients. According to an updated FDAnews release, FDA observed a 1,000 mL bottle of the medication with visible, white, floating material that FDA later identified as a fungus. Citing concerns that the contamination may be present in other budesonide solution products from The Compounding Shop, FDA is advising health care providers to “immediately quarantine any budesonide solution products from The Compounding Shop, and not to administer it to patients.” FDA issued a similar warning about sterile medications produced and distributed by the company in May 2013 after an inspection raised concerns about lack of sterility assurance.