A Digitek class action lawsuit filed on the heels of April’s Digitek recall raises serious questions about the way the defective pills were made. According to the Digitek class action lawsuit, a US plant that made some of the defective Digitek tablets was the subject of a Food & Drug Administration (FDA) warning letter in 2006.
The Digitek class action lawsuit, filed in US District Court in New Jersey, says that the FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. According to the complaint, some of the faulty Digitek came out of that plant. The Digitek lawsuit also claims that another FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency. READ MORE
