The FDA Has an Eye on The Compounding Shop Because of Fungus Concerns
A compounding pharmacy in Florida—The Compounding Shop—has been raising red flags over at the U.S. Food and Drug Administration (FDA) for quite a while now. After last year's fungal meningitis outbreak caused by tainted steroid shots from New England Compounding Center, there has been an increased awareness about some of the dangers of compounding pharmacies.
Back in May, the FDA put out a press release cautioning health care providers, hospital supply managers, and pharmacists about concerns they had with practices they encountered at The Compounding Shop. They said that they had concerns about a lack of sterility assurance for sterile drugs produced at and distributed by the site and they felt the products should not be administered to patients.
Now, the FDA has released another warning about a specific product from The Compounding Shop—budesonide solution. Budesonide solution is used for nasal irrigation and the FDA observed a bottle of it that had visible, white floating material. The material was identified as fungus and now there is a concern that more of The Compounding Shop's budesonide solution may have fungus as well. The FDA has told 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, but as of right now, the FDA isn't aware of any action being taken to rectify the problem.
If you suspect that you fell ill after receiving tainted budesonide solution, it's important that you contact a medical professional right away and also report the problem to the FDA's MedWatch Adverse Event Reporting program. If you live in Texas, Oklahoma or Arkansas, contact the compounding pharmacy attorneys at The Girards Law Firm for a free consultation today at 888.333.9709.