April 25, 2008—Actavis Towtowa announced a recall of Digitek as a result of a manufacturing defect that resulted in production of the pills at twice the approved level of Digoxin. The FDA has designated the recall as Class 1, indicating the risk involves serious health problems or death.
The defective pills can cause digitalis toxicity in those Digitek patients suffering from renal failure. Actavis announced it has received 11 reports of illnesses and injuries in patients taking Digitek. The risk potentially goes back as far as March 2006.
Digitek often is prescribed for patients with a weak heart or abnormal heartbeats. The active ingredient in Digitek is Digoxin, which in elevated doses can result in nausea, depress a patient's blood pressure or slow down the heart rate.
The drug is distributed by Mylan Pharmaceuticals under the Bertek label and by UDL Laboratories. |
