Nov. 13 (Bloomberg) -- Actavis Group hf said U.S. regulators sued seeking a permanent injunction against its subsidiary that makes the heart drug Digitek.

Iceland-based Actavis said the U.S. Department of Justice, took the action on behalf of the Food and Drug Administration against its Actavis Totowa LLC subsidiary, according to a statement today on Business Wire. The company in April recalled all lots of Digitek because they may have contained twice as much medicine as they should.

Actavis said it has been working to meet the FDA's manufacturing standards for its Totowa facility in Little Falls, New Jersey, and views the complaint as ``one step in a long regulatory process.''

``Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made,'' John LaRocca, Actavis Inc.'s counsel. To this point, the FDA has not acted,''

Digitek is a form of digitalis, a chemical derived from the foxglove plant that's been used as a heart medicine since the 18th century. The medication is sold generically as digoxin by several companies and is prescribed to treat heart failure and abnormal heart rhythms. Excess dosing in patients with kidney failure may cause nausea, dizziness, low blood pressure, or even death, the FDA said.

Actavis makes the drug for Mylan Inc., which distributes it under its Bertek and UDL brands. Actavis was taken over in July 2007 by billionaire Bjorgolfur Thor Bjorgolfsson and his investment company Novator.

To contact the reporter on this story: Andrew Pollack in San Francisco at apollack1@bloomberg.net

Last Updated: November 13, 2008 19:04 EST