Digoxin Voluntary Recall May 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 (R)
(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 ingredients that is appropriate. Digitek(R) 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.
Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at www.actavis.us.