FDA has announced that budesonide nasal irrigation solution produced by The Compounding Shop in St. Petersburg, FL may be contaminated with fungus and should not be given to patients. The agency is concerned that this fungus may also be present in various other products manufactured by The Compounding Shop.
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What’s the Problem?
According to the FDA Press Release, an investigation of practices at The Compounding Shop has identified a white, floating fungus in a 1000 mL bottle of budesonide solution. As a result, the administration is advising healthcare providers to quarantine any budesonide solution products from The Compounding Shop, and not administer them to patients. If a drug marketed as sterile has microbial contamination, it places patients at risk of bacterial infections and other serious health complications.
The FDA has advised The Compounding Store that it is in the best interest of public health to recall all sterile products from the market immediately. The company informed the FDA that it is currently in the process of recalling these products and notifying customers of the problem. Healthcare providers and hospital staff should take a comprehensive inventory of their medical supplies, remove any sterile products produced by The Compounding Store, and await further instructions from the company. Patients who have been administered any product produced by The Compounding Shop should contact their healthcare provider right away.
Compounding Pharmacy Recalls on the Rise
The Compounding Shop recall is just the latest in a series of similar actions taken by U.S. compounding pharmacies. In 2012, a fungal meningitis outbreak caused by steroid injections produced by the New England Compounding Center (NECC) caused 24 deaths and over 300 injuries. As a result of these problems, NECC closed its doors and has yet to resume operations.
Do I Have a Compounding Shop Budesonide Nasal Solution Recall Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Compounding Shop Budesonide Nasal Solution Recall lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
If you or somebody you know has been injured by a contaminated medicine manufactured by The Compounding Shop, you should contact our law firm immediately. You may be entitled to compensation by filing a Compound Shop Recall Suit and we can help.