The FDA recently sued a Texas compounding pharmacy, Specialty Compounding, of Cedar Park, Texas. At least 17 patients suffered from complications from contaminated drugs from the pharmacy.
In August 2013, the FDA received 17 reports of adverse events to patients at two hospitals in Corpus Christi. All of the patients contracted bacterial infections after receiving calcium gluconate in an IV. The calcium gluconate was made by Specialty Compounding. Calcium gluconate is used to treat a variety of conditions, including some heart conditions, black widow spider bites, and a calcium deficiency. The bacteria involved can infect people with compromised immune systems, and can be hard to treat.
On August 9, 2013, the pharmacy recalled all of its unexpired sterile drug products that had been distributed since February 2013. The FDA then analyzed samples of the drugs and found them contaminated with several strains of bacteria. Investigators from the FDA also saw unsanitary conditions and violations of good manufacturing practices.
In its lawsuit, the FDA alleges that the drugs made by the pharmacy should be considered unapproved new drugs, because they distributed the drugs without good clinical studies. They also consider them adulterated because they contain contamination. The FDA also visited the facility a month after the initial inspection, and found that it was still unsanitary, even though the defendants promised to fix the violations. The FDA is seeking an injunction, the costs of the investigation, and is demanding that the pharmacy’s manufacturing processes be corrected.
Unfortunately, this is far from the first compounding pharmacy to be involved in distributing tainted drugs. Drug manufacturers have a duty to consumers to make their products safe for consumption, and if they fail to do so, they can be held legally liable. If you have been harmed by a contaminated drug, call the defective drug attorneys at Kennedy Hodges at 888-894-0119. You can also reach out to us on Twitter.