FDAnews Drug Daily Bulletin

Indiana Compounder Indicted on Conspiracy, Drug Potency

June 29, 2017

Pharmakon Pharmaceuticals executives routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment.

According to the indictment, at least three infants experienced life-threatening effects after being administered painkillers 25 times stronger than the label indicated.

“Companies that do not meet federal manufacturing standards, especially when dealing with highly potent drugs like fentanyl meant for vulnerable populations, put the health and safety of American consumers at great risk,” said FDA Commissioner Scott Gottlieb.

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