April 28, 2008 -- All lots of Digitek tablets distributed by Mylan Pharmaceuticals and sold under the labels "Bertek" or "UDL" are being recalled because they may contain a dangerous double dose of their active ingredient.
"Tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate," states an Actavis Totowa news release posted on the FDA's web site.
Double-strength tablets pose a risk of digitalis toxicity, which can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, slow heart rate, and death. Actavis Totowa says it has received "several reports of illness and injuries."
Patients with medical questions should contact their health care provider. For other information, call the Mylan recall line at (888) 276-6166 Monday through Friday, from 8 a.m to 5 p.m. Eastern time, or visit the Actavis web site.
To report side effects to the FDA, call 800-FDA-1088 or visit the FDA's MedWatch web site.