INDIANAPOLIS (AP) — Two central Indiana compounding pharmacy executives face federal charges stemming from drug-potency problems, including powerful painkillers that were administered to infants.
Sixty-four-year-old Paul J. Elmer and 62-year-old Caprice R. Bearden are charged with distributing over- and under-potent drugs, defrauding the government and interfering with and obstructing the Food and Drug Administration.
Elmer was Pharmakon Pharmaceuticals’ owner-president, while Bearden was its compliance director.
Prosecutors say Bearden received about 70 notices indicating painkillers Pharmakon produced in Noblesville were either under- or over-potent. She told Elmer, who allegedly didn’t alert any customers and didn’t recall any of the drugs.
Prosecutors said Thursday three infants at an Indiana hospital received a painkiller nearly 25 times stronger than labeled, and one needed emergency treatment.
Elmer has pleaded not guilty, while Bearden hasn’t been arraigned.