DALLAS (CN) – Federal prosecutors filed a criminal misdemeanor information charging Dallas-based ApothéCure and its owner Gary Osborn with shipping an incorrectly labeled drug that killed three people.
Two lots of misbranded injectable colchicine “led to the deaths of three people in the Pacific Northwest,” the Justice Department said in a statement.
Colchicine is used to prevent gout attacks in adults and to relieve the pain of gout attacks when they occur.
ApothéCure and Osborn are accused of violating the Federal Food, Drug and Cosmetic Act.
ApothéCure shipped 72 vials of compounded colchicine to a now-defunct medical center in Portland, Ore., in February 2007, prosecutors said. Within a month, three patients in Washington and Oregon who were given the drug died of organ failure and colchincine toxicity.
“FDA testing of vials selected from the lethal shipment revealed that some of the vials were super-potent, containing 640 percent of the level of colchicine declared on the label,” prosecutors said in the statement. “Other vials were determined to be sub-potent, and contained less than 62 percent of the declared levels on the labels.”
Attorneys general in Texas and Order filed civil complaints against ApothéCure and Osborn, the Justice Department said.