Dear All:
Please take a few moments to review the announcement below concerning the all-lots recall of Digitek oral digoxin tablets. The distribution of affected lots through several manufacturers/distributors was quite extensive. The issue is that some tablets were double-thick and at risk of containing double the labeled dose. The affected lots have been pulled and replaced with digoxin available through other sources. Patients should check their prescription vials – or take them to their pharmacy for inspection and replacement, if needed. A telephone number for inquiries is provided below.
Most of you taking this drug have probably already heard this news from your physician or pharmacy. This message is being sent as a precaution for those who may not have heard.
-The Pulmonary Hypertension Association
PRESS RELEASE
Double-Thick Digoxin Recalled
BETHESDA, MD, 28 April 2008 —
Actavis Totowa LLC on Friday announced a Class I recall http://www.actavis.us/en/media+center/newsroom/articles/digitek+recall.htm of all lots and strengths of Digitek oral digoxin tablets because some tablets are double the normal thickness and may contain twice the labeled amount of the heart medication.
The tablets were distributed by Mylan Pharmaceuticals Inc. under a Bertek label and by UDL Laboratories under a UDL label, according to Actavis.
Patients with kidney failure who use the recalled tablets are at risk of digoxin toxicity, which can be deadly, Actavis stated. Symptoms of digoxin toxicity include nausea, vomiting, dizziness, low blood pressure, and abnormal heart beat.
Actavis has received several reports of illness related to the faulty tablets.
The company asked customers with questions about the recall to call
888-276-6166 Monday through Friday 8:00 a.m. to 5:00 p.m. Pharmacies should return unused Digitek tablets to their place of purchase, according to Actavis.
