According to the federal government, at least 15 patients at two hospitals in Texas suffered from contaminated medications from a compounding pharmacy that has since recalled the medications. The U.S. government filed a lawsuit against both the Texas compounding pharmacy, Specialty Compounding, and its co-owners on February 23, 2015.
Contact the Texas Injury Attorney Group to learn more about pursuing a claim for compensation if you took a medication and suffered complications. There is no out-of-pocket cost to speak with us, and we can connect you with an affiliated attorney who can assist you throughout the legal process.
FDA Receives Reports of
The U.S. Food and Drug Administration (FDA) announced 15 adverse event reports in August 2013 from patients at two Corpus Christi hospitals. Each of the patients was given intravenous infusions of calcium gluconate manufactured by Specialty Compounding. However, after the infusions, the patients reportedly experienced bacterial infections of Rhodococcus equi. Calcium gluconate is typically used to treat a variety of conditions, including black widow spider bites, rickets, calcium deficiency, and some heart conditions.
Rhodococcus equi typically causes infections in grazing animals, but the disease can infect patients with compromised immune systems, including AIDS patients, and can be difficult to treat. On August 9, 2013, the Texas compounding pharmacy announced a recall of all of its unexpired sterile drug products it had distributed since February 1 of that year. An FDA analysis of the samples of the calcium gluconate found at the manufacturer’s facility found them contaminated with several strains of bacteria, according to reports.
FDA investigators also reportedly noted violations of good manufacturing practices as well as unsanitary conditions, alleging that the company introduced and manufactured misbranded medications and unapproved new medications. Investigators also allege that the company distributed some of the drug products without prescriptions for individual patients.
According to the FDA, Specialty Compounding’s drugs are unapproved new drugs under law because there are no published well-controlled, adequate studies of those products manufactured and marketed by the company for any indication. The FDA maintained that the drugs are misbranded because the “sterile” drugs actually contain microbiological contaminations. The FDA reportedly observed the same deficiencies and unsanitary conditions in a March 2013 inspection and claims the company failed to correct these complaints despite promises to do so.
Contact Us for More Information About Your Options
If you or someone you love took a medication and you experienced life-threatening side effects or complications, the Texas Injury Attorney Group can help. In a free consultation, we can answer your questions. If you have a case, we can connect you with an affiliated attorney who can assist you throughout the legal process.