Class I Recall Issued for Digitek Tablets

Today the Actavis Totowa LLC in conjunction with the FDA
issued a Class I recall of all Digitek tablets. Digitek is used to treat
abnormal heart rhythms and heart failure; however, the company has learned that
some pills may be twice as thick and contain double the approved level of the active ingredient.
Taking these double strength tablets could result in an elevated risk of
digitalis toxicity in patients with renal failure. Digitalis toxicity can cause
low blood pressure, dizziness, cardiac instability, nausea, vomiting, and
bradycardia (a heart rate below 60 bpm).The tablets are distributed by Mylan Pharmaceuticals Inc,
under a “Bertek “label, and also by UDL Labratories Inc, under “UDL” a label.

Several reports of illnesses and injuries have been
reported. Patients should contact their healthcare professional with questions.
Retailers are encouraged to remove all recalled products from their shelves and
return to their place of purchase. Additiional information can be found at www.actavis.us.