News and Announcements

 
Drug Recall Oral Use Digitek (digoxin)

On April 25, 2008, Actavis initiated a class 1 recall of Digitek (digoxin) all strengths for oral use. The products are also distributed under the Bertek label by Mylan Pharmaceuticals and UDL. This voluntary recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. Those tablets may contain twice the approved level of active ingredient than is appropriate. Double strength tablets may pose a risk of 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 illness and injuries have been received. Digitek is used to treat heart failure and abnormal heart rhythms.

Sudden discontinuation of Digitek without your doctor's knowledge can also cause serious health problems. Please speak with your doctor immediately about this Digitek recall.

What you should do:

If you are currently using Digitek, please contact your prescriber immediately. You and your prescriber should discuss the best therapy options for you, and then obtain a 10-14 days supply prescription to be filled locally. Medco will be sending notification to all patients who are currently taking the medication.

• If you have refills for Digitek you can safely refill by calling the toll free number located on your prescription medication bottle to receive medication which is not impacted by the product recall.
• If you do not have refills remaining, please obtain a new mail order prescription and mail it to Medco to receive medication which is not impacted by the product recall.

For more information:

For Product Return Information and Reimbursement and any other inquiries, Actavis has provided a toll free number for patients to obtain a product return kit by calling, 1-888-276-6166 Monday through Friday, 8 a.m. to 5 p.m. eastern time or visit www.actavis.us.

If you have any additional questions or concerns relative to this medication recall or about your prescription drug benefit, please call the phone number on your prescription bottle label or ID card.

If you have medical questions please contact your health care provider.