Two pharmacy executives face federal charges for failing to recall painkillers after three infants were sickened due to potency issues with the medications, reports CNN.
Paul Elmer, president and owner of Pharmakon Pharmaceuticals, and Caprise Bearden, the company's director of compliance, were indicted on 10 charges involving the distribution of drugs with inaccurate potencies — including fentanyl, morphine sulfate and midalozam — to hospitals in Illinois, Indiana, Maryland and Virginia, according to an indictment released Thursday.
The indictment alleges the compounding pharmacy regularly distributed the drugs without waiting for test results to confirm their potencies. When Pharmakon received test results signaling the potency was sometimes double of what the label indicated, the company failed to notify hospitals or the Food and Drug Administration about the issue, according to federal officials. The indictment also alleges Ms. Bearden lied to FDA officials, claiming the company never received test results outside the normal potency range, reports IndyStar.
Three infants experienced serious adverse events after receiving the affected drugs, according to the FDA.
Mr. Elmer and Mr. Minkler's trial is set for August 21. The executives could face prison time and a minimum $250,000 fine, each, if convicted, reports CNN.
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