FDA Warning: Budesonide Solution from The Compounding Shop

September 30, 2013 — The U.S. Food and Drug Administration (FDA) has published an updated Drug Safety Communication to warn that budesonide solution sold by The Compounding Shop could be contaminated with mold. The firm has not issued a recall and the FDA is not aware of any action taken by the firm to remove the products from the market.

FDA investigators observed visible particles of white, floating material in a 1000 mL bottle of budesonide solution, which is commonly inhaled to prevent asthma attacks. According to the warning:

“FDA identified the 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.”

The Compounding Shop previously recalled all sterile medicine in May 2013 over concerns about sterility. FDA investigators observed problems with quality control procedures.

483 Warning Letter

On September 3, the FDA issued a 483 Warning Letter, which cited the company for failing to address 3-6 customer complaints in the last 6 months about budesonide solutions that were “cloudy, had precipitate, or floating matter.” FDA investigators found that the bottles were simply thrown away without investigating the reason for the contamination or determining whether other batches of the drug were contaminated.

No adverse events have been reported, but people who use contaminated medicine are at risk of infection. The FDA has stepped up its enforcement of compounding pharmacies after a deadly outbreak of fungal meningitis last year was traced to moldy vials of methylprenisolone acetate.

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