It has recently come to light that there was a recall notice for Digitek (generic digoxin) as far back as March 2006, and that a recall notice was published on the home page of the North Carolina Board of Pharmacy (NCBOP). The drug was recalled (again) two weeks ago due to the existence of “double-strength” tablets that could cause digoxin toxicity, which may result in bradycardia, nausea, vomiting, low blood pressure, cardiac instability and death.
Digitek is manufactured by Actavis Totowa and is presecribed to treat abnormal heart rhythms and heart failure. Mylan Pharmaceuticals distributes the drug under a “Bertek” label and by UDL Laboratories under a “UDL” label. Several people have come forward with complaints of injury while taking this drug.
A Digitek class action lawsuit has been filed in the United States District Court in New Jersey against Actavis. According to the suit, the Food and Drug Administration (FDA) issued a warning letter to the company back in August 2006 for failing to provide periodic safety reports as its plant in Little Falls, NJ. The current suit alleges the faulty pills came out of that plant. Additionally, the suit claims an FDA inspection in the same year revealed six potentially dangerous and unexpected adverse effects that were never reported to the agency.