Actavis Totowa has recently issued a recall of all lots of Digitek. All Digitek tablets have been recalled because they may contain a double dose of their active ingredient digoxin. Increased consumption of digoxin can result in digitalis toxicity – a condition which causes the person to suffer serious side effects or death.

Digitek is distributed by Mylan Pharmaceuticals and is sold under the labels “UDL” or “Bertek.”

About Digitek

Digitek (Bertek, UDL, digoxin) is prescribed to patients suffering heart failure or irregular heart beats. When taken properly Digitek allows the heart to beat strongly at a normal pace. If Digitek (or digoxin) is taken in larger amounts it may result in severe side effects or digitalis toxicity in the user.

The makers of Digitek recalled all tablets because of the possibility of the distribution of double dose tablets. The tablets containing the double dose of Digitek were larger and thicker in size, alerting makers to the possibility of increased strength.

FDA Digitek Recall

On April 25, 2008 the FDA issued a Class 1 recall of all lots of Digitek. They issued the following statement which may be found on the official FDA website.

“FOR IMMEDIATE RELEASE -- Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by 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 it appropriate.

Digitek® is used 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. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.

Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at Actavis's website.

Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.”

Digitek Recall Victims

Although the makers of Digitek voluntarily issued a recall of the tablets, many people may have unknowingly consumed the defective tablets. The consumption of double strength Digitek (digoxin) tablets results in digitalis toxicity - a condition which is extremely likely to develop in patients who also have renal failure or are taking a diuretic.

If the Digitek recall tablets caused you or a loved one to become ill or if a loved one has passed away unexpectedly please contact McEwen Law Firm today. Our attorneys are experienced with the severe side effects and symptoms caused by Digitek and are dedicated to providing you with the compensation you deserve.

If you would like additional information about the Digitek recall or would like to contact an attorney please call us at (800) 732-3070 or use our free case consultation request form. We get our clients maximum compensation for damages.