Digitek-brand digoxin heart tablets are being recalled because of a potential safety risk, says the U.S. Food and Drug Administration. Some tablets may be double the appropriate thickness and contain twice the approved level of active ingredient, United Press International reported.
The products are made by Actavis Totowa LLC and distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
Digitek is used to treat heart failure and abnormal heart rhythms. Double-strength tablets could cause digitalis toxicity in patients with renal failure, resulting in nausea, vomiting, dizziness, low blood pressure, cardiac instability and brachycardia -- a below-normal heartbeat. Excessive digitalis intake can also cause death.
Patients and caregivers with questions can call 888-276-6166. Any adverse reactions should be reported to the FDA's MedWatch Program at 800-332-1088.