AUSTIN, Texas (CN) - At least 17 patients at two Texas hospitals suffered from contaminated drugs from a compounding pharmacy that has recalled the drugs nationwide, the federal government says.
The United States sued Specialty Compounding, of Cedar Park, Texas, and its co-owners Raymond L. Solano III and William L. Swail on Monday in Federal Court.
In August 2013, the Food and Drug Administration received 17 reports of "adverse events" to patients at two Corpus Christi hospitals, the complaint states. All the patients suffered bacterial infections of Rhodococcus equi, after receiving intravenous infusions of calcium gluconate made by Specialty Compounding.
Calcium gluconate is used to treat a wide variety of conditions, including calcium deficiency, rickets, black widow spider bites and some heart conditions.
Rhodococcus equi generally causes infections in grazing animals, but it can infect people with compromised immune systems, such as AIDS patients, and can be difficult to eradicate.
Specialty Compounding on Aug. 9, 2013 recalled all of its unexpired sterile drug products distributed since Feb. 1 that year.
The FDA then analyzed samples of calcium gluconate at Specialty Compounding's facility and found them contaminated with many strains of bacteria, including Kocuria kristinae, Kocuria varians, Gardnerella vaginalis, Streptococcus pluranimalium, and Streptococcus thoraltensis, according to the complaint.
FDA investigators also saw unsanitary conditions and violations of good manufacturing practices (CGMP). FDA investigators "documented that defendants manufacture and introduce into interstate commerce unapproved new drugs and misbranded drugs," and that "defendants distributed some of their compounded sterile drug products in interstate commerce without prescriptions for identified individual patients," according to the complaint.
The FDA considers defendants' drugs to be unapproved new drugs under law because "there are no published adequate and well-controlled clinical studies of those drugs manufactured and distributed by Specialty Compounding for any indication." It said the drugs are adulterated and misbranded because the "purportedly sterile drug products" contain microbiological contamination.
The complaint describes a myriad of violations of good manufacturing practices by Specialty Compounding.
In a March 2013 inspection, the FDA says, it observed the same unsanitary conditions and deficiencies, which defendants never corrected despite promises to do so.
"The FDA believes that use of these products would create an unacceptable risk for patients," Dr. Janet Woodcock said in an Aug. 11, 2013 FDA news release about the drug recall. "Giving a patient a contaminated injectable drug could result in a life-threatening infection."
The FDA seeks an injunction, corrected manufacturing processes, and costs of the investigation.
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