Drug Digitek Being Voluntarily Recalled

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Morristown, NJ - The Actavis Totowa LLC, is initiating a Class I nationwide recall of Digitek for oral use. The products are distributed by Mylan Pharmaceuticals. This recall is being done with FDA knowledge.

During the manufacturing process, they believe that the pills were made twice as thick as well as having twice the approved amount of the active ingredient.

Digitek is a drug taken orally to treat individuals with heart failure or an abnormal heart rhythm. With the knowledge that there are double strength tablets out there, it poses a severe risk of digitalis toxicity in patients with renal failure. Nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia (defined as a resting heart rate of under 60 beats per minute) are the signs of toxcity. Death is also possible. To date, there have been several reports of illnesses and injuries.

Customer inquires are to be addressed by contacting Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. It's also urged that customers contact their doctors, as well.

Retailers are urged to return the product to their place of purchase.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.