Following Recalls, Digitek Manufacturer to Remain Shut Down

The U.S. Department of Justice and the FDA have taken steps to continue barring Actavis Totowa from manufacturing and distributing generic drugs. The actions were taken following a series of serious manufacturing problems which resulted in a nationwide Digitek recall earlier this year when double strength tablets were produced, and a subsequent recall that involved potential issues with over 65 different generic drugs.

On November 14, 2008, the Justice Department announced that the United States government has filed a lawsuit seeking a permanent injunction against Actavis Totowa LLC, their parent company Actavis Inc. and two of the company’s executives, barring them from manufacturing and distributing generic drugs until they can demonstrate their ability to comply with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act.

Actavis Totowa has received a number of warnings for distributing adulterated and misbranding drugs, and the FDA has found numerous, recurring violations of Good Manufacturing Practices during their inspections of the company’s facilities.

In April 2008, manufacturing problems at Actavis Totowa’s plant in New Jersey resulted in a recall of Digitek tablets, a generic form of digoxin , which were twice as thick as they were supposed to be and contained up to twice the appropriate active ingredient.

As a result of the Digitek problems, hundreds of users have claimed that they suffered serious injury, such as renal impairment, cardiac arrhythmias and death, caused by digoxin overdose. A number of these users have filed Digitek lawsuits against Actavis and their distributors, and additional lawsuits are being filed every week.

On August 1, 2008, Actavis Totowa was also forced to recall over 65 different generic drugs due to non-compliance with Good Manufacturing Practice requirements at the same New Jersey plant. Although Actavis has claimed that these tablets do not pose any health risks, the FDA required them to recall millions of generic painkillers, antidepressants, hypertension, blood pressure and diet drugs.

The Department of Justice filed for the permanent injunction after Actavis Totowa recently informed the FDA that they wanted to restart manufacturing of drug products. However, the FDA still does not believe that they have demonstrated that they can follow the Good Manufacturing Practice requirements.

Actavis Totowa has indicated that they view the action as one step in a long process of regulation and they claim that they remain fully committed to collaborating with the FDA to ensure that their facilities and products comply with Federal regulations.