New Jersey -- 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.
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.
This recall is being conducted with the knowledge of the Food and Drug Administration.
If you or a loved one has been adversely harmed by taking a bad batch of Digitek, please contact Anapol Schwartz, personal injury and wrongful death lawyers located in Philadelphia, Pennsylvania and Cherry Hill New Jersey. Find out if you or your family qualifies for a lawsuit or class action Digitek lawsuit.
Subscribe to:
Post Comments (Atom)

0 comments:
Post a Comment