August 14, 2008
All lots of digitek tablets sold under the labels "Bertek" and "UDL" recalled because of possible double dose.
All lots of Digitek tablets distributed and sold under the labels "Bertek" or "UDL" are being recalled because they may contain a dangerous double dose of their active ingredient.
Digitek pills are used to treat heart failure and abnormal heart rhythms. The company Actavis Totowa makes the recalled Digitek pills.
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.
Source: webmd.com
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