A compounding pharmacy makes personalized medications for patients. These drugs are prescribed by doctors and then are actually mixed together at these compounding facilities. However, what most people don’t know is that these drugs are not FDA-approved. The FDA may investigate a compounding pharmacy after problems are reported.
The Food and Drug Administration is currently investigating Guardian, a compounding pharmacy in Dallas, for compounding a dangerous drug, using a prohibited substance in compounded drugs, and producing drugs in unsanitary conditions. The FDA sent out a letter on November 3 highlighting each of these allegations.
Between April and June, the FDA received more than 40 reports of vision problems after patients received injections of a drug compounded by Guardian. These reports noted that post-eye surgery, some individuals were developing severe vision problems, including the inability to see colors, sensitivity to light, blurred vision, and poor night vision.
These adverse events are still under investigation. They may have been caused by the negligent drug-producing practices of Guardian. In September and October of 2016, the FDA inspected Guardian’s facility and found “serious deficiencies.” The FDA discovered Guardian had been compounding drug products using grapeseed oil, a substance not permitted under the Food, Drug, and Cosmetics Act. Moreover, the FDA found unsanitary conditions throughout the facility.
In the letter to Guardian, the FDA wrote, “your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.”
GoldenbergLaw represented 65 clients in the 2012 Massachusetts-based NECC compounding pharmacy case where 76 people died and over 800 people developed meningitis. Thousands more needed to be tested for meningitis-like symptoms. This was a result of contaminated and dirty labs which cause mold to form in their compounded steroid injectable product. This resulted in a settlement of over $200 million and also in criminal charges against the people responsible.
GoldenbergLaw is committed to holding negligent parties accountable for their actions. We have over 30 years of experience litigating claims involving compounding pharmacies. Contact Partner Laura Pittner for questions.