The FDA alerted patients and health care providers that budesonide solution, which is used for nasal irrigation, from The Compounding Shop in St. Petersburg, Florida, may be contaminated and should not be used by or administered to patients. The FDA observed a 1000 mL bottle of budesonide solution from The Compounding Shop that contained visible, white, floating material. The 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.
Drug products that are for oral inhalation — such as the budesonide solution from The Compounding Shop, which is labeled “for inhalation only” -- are required to be sterile. Contaminated drug products, whether used by inhalation or otherwise, put patients at risk for infection. The budesonide solution from the Compounding Shop is also labeled for nasal irrigation, which may be confusing to consumers.
The FDA has advised The Compounding Shop that it is in the best interest of public health to take action to remove the budesonide solution products from the market. However, to date, the FDA is unaware of any action taken by The Compounding Shop to remove these products from the market.
See the FDA Safety Announcement
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication