Actavis Totowa LLC is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. Digitek® is used to treat heart failure and abnormal heart rhythms.

The products are distributed by:

• Mylan Pharmaceuticals Inc., under a "Bertek" label
• UDL Laboratories, Inc. under a "UDL" label.

The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure; digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been received.

Any customer inquiries related to this action should be addressed to 1 (888) 276-6166, with customer service representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at www.actavis.us.

For more information, please visit the FDA website.