KV Subsidiary Agrees to Settle With Justice Over Field Alerts

Ethex, a KV Pharmaceutical subsidiary, has agreed to plead guilty to two felony counts and pay $25.8 million in fines and restitution to resolve a Justice Department investigation into its failure to file field alert reports.

Under the settlement, which is subject to court approval, Ethex will plead guilty to failing to file field alert reports for out-of-specification dextroamphetamine and propafenone tablets in September 2008, KV said.

The company recalled several lots of generic drugs in November 2008, including dextroamphetamine and propafenone, because they might have contained oversized tablets with as much as twice the amount of active ingredient.
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