September 30, 2013 — The Compounding Shop of St. Petersburg, Florida is facing more warnings from the U.S. Food and Drug Administration (FDA) over concerns that budesonide solution is not sterile. No injuries have been reported. The FDA is not aware of any action taken by The Compounding Shop to remove the product from the market.
FDA investigators found that 1000 mL bottles of budesonide solution, which is commonly used as an anti-asthma inhalant, was contaminated with visible particles of white, floating material. The investigators warned:
“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.”
483 Warning Letter
The FDA warning follows a 483 Warning Letter issued on September 3. FDA inspectors found that the company had received 3-6 reports of contaminated budesonide in the last six months. When the contaminated products were returned, The Compounding Shop simply threw them away and did not investigate the source of contamination or whether other batches were also contaminated.
The Compounding Shop Recalls All Medicines
The Compounding Shop was previously forced to recall all lots of all sterile medicines in May 2013, after the FDA found problems with quality control procedures.
People who use contaminated medicine can develop life-threatening infections. The FDA has substantially stepped up its oversight of compounding pharmacies after a deadly outbreak of fungal meningitis sickened about 750 people last year, killing 64.
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