Actavis Faces Shutdown of Plants after Drug Recalls and Poor Safety Standards
After a spate of product recalls involving its Digitek tablets, Iceland-based drug manufacturer Actavis, is facing a lawsuit by U.S. attorneys who want a shutdown of the company’s three plants until such time as they are made compliant with FDA laws for manufacturing and testing.
The move comes after the company recalled its Digitek tablet for heart conditions. Digitek is prescribed primarily for the treatment of heart failure and other abnormal heart disorders. Over dosage however has been found linked to dizziness, low blood pressure, and even death, in patients who are already suffering from kidney problems. In April, Actavis recalled stocks of Digitek after fears that some tablets had been produced in an extra thick form, raising the possibility of overdosing.
This product recall was followed by another one in August that was prompted by FDA inspection at its facility that revealed non-compliance with agency standards for manufacturing practices. This second product recall included all drug manufacturers at the company’s Little Falls plant in New Jersey.
The company has two other facilities in Totowa. The FDA claims that it has inspected the three facilities a total of five times between January 2006 and May 2008, and had on all occasions, found the safety standards lacking. These unsafe practices include incomplete lab records of testing data, and failure to follow its own stability testing procedures. Actavis, it was found, had failed to ensure that the conditions under which the drugs were tested were the same conditions under which they were used. Test samples also didn’t meet the company’s own standards. The company on its part, has issued a press release claiming that it has been focusing efforts on meeting compliance standards, and has invited the FDA to revisit its facility for another inspection, but has not heard from the agency.
The lawsuit was field by U.S. Attorney Christopher Christie and the Department of Justice’s Officer of Consumer Litigation and seeks a permanent injunction that would bar the company’s three plants as well as the executives of the company, Douglas Boothe and Sigurdur Olafsson from manufacturing drugs until they are able to bring manufacturing conditions under the compliance of FDA requirements.
The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of product recalls. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.
