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KV Pharmaceutical Unit Pleads Guilty

Ethex generic drug unit has pleaded guilty to two criminal charges that it failed to promptly inform regulators about dangerous manufacturing problems.

ST. LOUIS (AP) -- The Ethex generic drug unit of KV Pharmaceutical Co. has pleaded guilty to two criminal charges that it failed to promptly inform regulators about dangerous manufacturing problems.

The company pleaded guilty Tuesday in U.S. District Court in St. Louis.

The U.S. Attorney's office said Ethex did not alert regulators about problems with its oversized tablets of a heart medication and one used to treat attention deficit disorder in children.

Ethex was fined $23.4 million, and ordered to reimburse $2.3 million to Medicare and Medicaid for their drug purchases.

KV Pharmaceutical is under a 2009 federal court decree that regulates its drug manufacturing.

The company said last week it will shut down its Ethex unit, and looked forward to restoring normal business operations.

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