DIGITEK® (DIGOXIN) PILLS RECALLED

Patients who suffered a Digitek® (digoxin) overdose or Digitek (digoxin) toxicity should complete our short CONFIDENTIAL contact form on the right side of this page or call us immediately at TOLL FREE 1.888.93.law29 (or 1.888.935.2929).

Digitek (digoxin), sold under the Bertek and UDL labels, and also known as Cardoxin, Lanoxicaps or Lanoxin, was recalled in a Class I nationwide recall announced April 25, 2008. Actavis Totowa LLC (formerly known as Amide Pharmaceutical, Inc.), manufactures Digitek for distributors Mylan Pharmaceuticals Inc. and UDL Laboratories.

Digitek, a medication for patients with certain heart conditions, was recalled in April 2008 because an unknown amount of the drugs contained twice the recommended dosage. An overdose of Digitek can cause digitalis toxicity, a potentially fatal condition that can also cause excessively low blood pressure, dizziness, nausea, vomiting, cardiac instability, bradycardia, irregular heartbeats, excessively slow or fast heartbeats, hallucinations, confusion, and seizures. Less severe symptoms include decreased appetite and fatigue. Obviously, patients on Digitek with these symptoms or other concerns should contact their doctor immediately.

Digitek is manufactured by the generic drug-maker ActavisTotowa and distributed in the United States by Mylan Pharmaceuticals under the label "Bertek” and by UDL Laboratories under the label "UDL."

Specifically, Digitek is prescribed for heart patients with mild to moderate heart failure and patients prone to atrial fibrillation (accelerated heart rate).

The Problem with Digitek

According to the manufacturer Actavis Totowa, Digitek 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, stated an Actavis Totowa spokesperson.

This is not the first time the FDA has warned about problems with Digitek. The FDA issued the company a warning letter in August 2006 for failing to provide safety reports at a Digitek manufacturing plant in New Jersey.

If you used Digitek please complete our short CONFIDENTIAL contact form on the right side of this page or call us immediately at TOLL FREE 1.888.93.law29 (or 1.888.935.2929). We will thoroughly examine your case, answer your questions, and inform you of your legal rights and options.

FDA Issues Alert on Digitek®

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution

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.

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.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Patients who suffered a Digitek (digoxin) overdose or Digitek (digoxin) toxicity should please complete our short CONFIDENTIAL contact form on the right side of this page or call us immediately at TOLL FREE 1.888.93.law29 (or 1.888.935.2929). We will thoroughly examine your case, answer your questions, and inform you of your legal rights and options.