ST. LOUIS (CN) – The U.S. government wants a federal judge to enjoin KV Pharmaceutical Co. from making and selling drugs under its ETHEX and Ther-Rx labels that haven’t been approved by the Food and Drug Administration. A February inspection allegedly revealed that the drug maker was distributing unapproved, mislabeled drugs.
Investigators allegedly documented 35 separate deviations from the current “good manufacturing practice” standards during their last inspection.
The United States requests an injunction preventing KV Pharmaceutical and its subsidiaries from distributing adulterated or mislabeled drugs. The government also seeks an order authorizing the FDA to inspect the company’s business records.
U.S. attorney Catherine Hanaway filed the action in Federal Court.