Manufacturing Flaw in the Congestive Heart Failure Drug Digitek Forces Market Recall
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.
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
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.
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