Violation Tracker Individual Record
Ethex Corporation, a wholly owned subsidiary of St. Louis-based drug manufacturer, KV Pharmaceutical Company, pleaded guilty to two felonies and was sentenced in connection with the manufacturing of oversized prescription drug tablets. The government had charged that, despite having knowledge that the two drugs did not meet required specifications, Ethex violated the law by intentionally withholding this information from the Food and Drug Administration (FDA). Given the seriousness of Ethex's conduct and the risk it posed to consumers of its drugs, the Justice Department pursued felony charges. According to charges presented in U.S. District Court in St. Louis, Ethex failed to submit required "field alert reports" to the FDA in 2008 concerning two drugs, propafenone and dextroamphetamine sulfate. Following the recommendations of a plea agreement, Judge E. Richard Webber sentenced Ethex to pay a fine of more than $23.4 million, pay approximately $2.3 million in restitution to Medicare and Medicaid for their approximate losses, and forfeit nearly $1.8 million to the United States.
http://www.justice.gov/opa/pr/kv-pharmaceutical-subsidiary-pleads-guilty-two-felonies-regarding-oversized-drugs (archived copy)