In August 2006, the Food and Drug Administration (FDA) sent a warning letter to Actavis for failing to provide periodic safety reports at its manufacturing plant in New Jersey, and a Digitek class action lawsuit says some of the Digitek included in an April 2008 recall was manufactured at that plant.

The Digitek class action lawsuit mentions Actavis’ previous warning while raising questions about the way the defective pills were made. The lawsuit also says a 2006 FDA inspection uncovered six potentially serious and unexpected adverse drug events for products that include generic Digitek from as far back as 1999.

Actavis recalled Digitek after realizing some tablets contain twice the active ingredient indicated on the label, which could lead to accidental overdose or death. Patients suffering from renal failure who take some of the recalled Digitek face a serious risk of digitalis toxicity. The company received reports of sick Digitek patients, prompting the recall. One patient, who is also a plaintiff in the Digitek lawsuit, said she experienced changed cardiac symptom episodes of nausea and dizziness. Another patient said he took the defective drug and it may have caused kidney damage.

Source: “Digitek recall blamed on shoddy manufacturing,” News Inferno, June 4, 2008.