Digitek Lawsuit

From LaWiki

Digitek (digoxin), distributed by Mylan Pharmaceuticals Inc., is a drug used to help the heart beat more strongly. It is used to treat conditions such as congestive heart failure and atrial fibrillation or atrial flutter (abnormal heart rhythms).

The FDA sent out a press release on April 25, 2008 stating that Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, was 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.

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