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KV Pharmaceutical Subsidiary Pleads Guilty to Two Felonies Regarding Oversized Drugs
Date:3/2/2010

wing the recommendations of a plea agreement that was filed today, 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.

Under the Food, Drug and Cosmetic Act, a drug manufacturer must thoroughly investigate why a drug fails to meet specifications, whether or not the drug has been distributed into interstate commerce. Moreover, when a manufacturer receives information concerning a significant chemical change in a distributed drug or a failure of a distributed drug batch to meet specifications, it is required to promptly file a field alert report with the FDA. A manufacturer's failure to file such a report, if done with the intent to defraud or mislead, is punishable by a term of up to five years' probation and a fine of $500,000 or twice the gross amount gained from the offense.

The government had alleged that in May 2008, KV and Ethex received complaints from a pharmacy in California and a distributor in Canada of oversized morphine sulfate pills, a pain-relief medication which had been manufactured by KV and distributed by Ethex. In response to the complaints, KV recalled specific lots of morp
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SOURCE U.S. Department of Justice
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