|Actavis recalled heart failure drug may have contained twice the approved level of active ingredient. Source: PharmaInteractive|
Actavis Totowa, a Morristown, N.J. manufacturing division of pharma company Actavis Group, has initiated a Class I U.S. recall of all lots of its heart failure treatment Digitek, as a precautionary measure.
The voluntary all-lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released, according to the FDA. The agency also said that the tablets may contain twice the approved level of active ingredient than appropriate.
Digitek is indicated to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure, the agency said. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive digitalis intake. The FDA has received several reports of illnesses and injuries.
Mylan Pharmaceuticals, under a Bertek label, and UDL Laboratories, under a UDL label, distribute the products. Bertek and UDL are affiliates of Mylan.