06/19/2008- Questions have been raised in a class action suit about Actavis Totowa, LLC and their product, Digitek. The tablets were recalled after they went on the market with twice the active ingredient that they should have contained.
It seems the plant that is responsible for manufacturing the defective product had been warned by the Food and Drug Administration (FDA) in a 2006 letter. The class action suit was filed in US District Court in New Jersey. The suit alleges that the manufacturer failed to provide periodic safety reports, which is why they were warned in 2006 by the FDA. Additionally, the suit claims that six potentially serious drug events going back to 1999, which were not reported to the FDA
Actavis Totowa, LLC is a United States manufacturing division of the international generic pharmaceutical company Actavis Group. Actavis manufactures the products for Mylan Laboratories, which are distributed by Mylan and UDL under the Bertek and UDL labels.