According to the charges, a KV internal investigation that began in May 2008 discovered sporadic instances of various oversized KV-manufactured drugs, including morphine sulfate, propafenone and dextroamphetamine sulfate. Propafenone is an anti-arrhythmia drug that is used to treat some kinds of heart disease. Dextroamphetamine sulfate is used to treat attention deficit disorder in children. The charges alleged that despite the fact that KV's internal investigation uncovered evidence of various oversized propafenone and dextroamphetamine sulfate tablets, Ethex did not file the required field alert reports with the FDA.
"Even though they were aware of serious manufacturing problems concerning their oversized drugs, Ethex failed to notify the FDA as required by law," said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division. "The Justice Department will vigorously prosecute those who pursue profits at the expense of consumer safety."
The case was investigated by the FDA's Office of Criminal Investigations and is being prosecuted by the U.S. Attorney's Office for the Eastern District of
SOURCE U.S. Department of Justice
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