Digitek Heart Failure Pill

Digitek (digoxin) is the #1 choice for treating congestive heart failure and abnormal heart rhythms in the United States. On April 25, 2008, Actavis Totowa LLC, the U.S. manufacturing division of the generic pharmaceutical company Actavis Group, voluntarily initiated a Class I nationwide recall of Digitek oral tablets of all strengths. Digitek is distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.

At the Actavis New Jersey facility where Digitek is made, improper manufacturing of drug products may have occurred for some time. In early 2007, the FDA sent Actavis a warning letter after its inspection showed that drug products manufactured in the facility were adulterated. The FDA criticized this facility's quality control unit, stating that it failed to "reliably establish the identity, strength, quality and purity of drug products manufactured and released onto the market." In fact, on August 1, 2008, Actavis Totowa LLC announced a voluntary recall of all drug products manufactured at this facility. The recall is at the pharmacy/retail level, and includes wholesalers and hospitals.

The voluntary recall of the Digitek tablets manufactured at the New Jersey Actavis facility occurred because tablets may have been commercially released in the U.S. market with double the thickness of the normal sized tablets. The flawed Digitek tablets may contain as much as twice the active ingredient, meaning they may have twice the strength of the recommended dosage. A double-strength tablet could cause serious digitalis toxicity, resulting in nausea, vomiting, dizziness, low blood sugar, cardiac instability, bradycardia and even death. In fact, Actavis Totowa has received numerous reports of illnesses and injuries due to patients who may have taken the double-strength tablets. For more information, please click on the following links:

• FDA warning letter to Actavis in 2006 regarding the same New Jersey facility where the Digitek pills are manufactured (PDF file)

• Digitek recall notice on the FDA’s website

• Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility (FDA post of Actavis Press Release, Agust 1, 2008)

Digitek is the only drug containing digoxin that was recalled from the U.S. market. Other digoxin brand name drugs include Lanoxin, Lanoxicaps and Cardoxin.

HO&P has filed numerous cases on behalf of victims and their families against manufacturers and distributors of dangerous drugs such as Digitek. If you know someone who may have suffered personal injuries, or who died after taking Digitek tablets, please fill out our questionnaire to the right of this page for a free consultation.