According to published reports from Bloomberg News, the Associated Press and the St. Louis Post Dispatch, KV Pharmaceuticals has reached an agreement with the U.S. Department of Justice regarding an investigation into Ethex Corp, its generic pharmaceutical marketing and distribution subsidiary.
KV Pharmaceutical must pay $27.6 million in fines and an administrative forfeiture to cover costs of the investigation. Additionally KV plans on ceasing operation of its Ethex generic drug business.
This agreement comes after Ethex plead guilty to criminal charges for not disclosing issues with two to its drugs.
The agreement with the U.S. Attorney and the Department of Justice is subject to court approval and revolves around the 2008 investigation into Ethex which halted production and recalled drugs after making oversized tablets.
Specifically Ethex plans to plead guilty to two felony counts of failure in 2008 to file field alerts for the generic drugs Dextroamphetamine and Propafenone.
These incidents of substandard medications were significant and could have adversely affected the health of many consumers. Had material screening been in place within the supply chain, these substandard materials would have been intercepted prior to them reaching a dispenser and ultimately the consumer.
To learn more about material screening solutions within the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.
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