New Jersey: Permanent Injunction Actavis Totowa

On November 13, 2008 Actavis, Inc. announced that the Department of Justice, on behalf of the Food and Drug Administration (FDA), filed a complaint seeking a permanent injunction against the business of its Actavis Totowa LLC subsidiary.

The company works to address compliance issues stemming from an inspection of the Actavis Totowa facilities by the FDA earlier this year to ensure the integrity of its manufacturing and quality systems.

Actavis views the filing of this complaint as one step in a long regulatory process, and is committed to working with the FDA in a timely manner.

On April 25, 2008, Actavis Totowa LLC initiated a Class 1 nationwide recall of Digitek(R) (digoxin tablets, USP, all strengths) for oral use. The products, manufactured by Actavis, are distributed by Mylan Pharmaceuticals, Inc. under the "Bertek" label and by UDL Laboratories, Inc. under the "UDL" label.

The recall followed an inspection conducted by the FDA that revealed operations at the Little Falls, N.J., facility which did not meet the FDA's or Actavis' standards for good manufacturing practices. Do you have a Digoxin lawsuit?

On August 1, the company initiated a precautionary, voluntary recall -- to the retail level -- of all drug products manufactured at its Little Falls facility.