Digitek Recalls

On April 28, 2008, drug manufacturers Actavis Totowa LLC issued a Class I nationwide recall of all Digitek® digoxin tablets distributed between March 2006 and April 2008. The pills may contain two times the acceptable dosage of the active ingredient.

Class I recalls are conducted when dangerous or defective products that predictably could cause serious health problems or death are released.

Digitek® tablets are prescribed for treatment of heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity. This could lead to serious and potentially fatal illness caused by overmedication, especially among individuals with renal insufficiencies.

Digitalis toxicity can cause among other things:

• Visual changes, changes in color perception -yellow-green distortion is most common, but red, brown, blue, and white also occur, halos, bright spots, blind spots, blurred vision
• Palpitations
• Irregular pulse, bradycardia (slow heart rate below 60 bpm)
• Dizziness, loss of consciousness
• Low blood pressure
• Loss of appetite
• Nausea/ vomiting
• Decreased urine output
• Excessive nighttime urination
• Cold sweats
• Difficulty breathing when lying down
• Death

Patients taking Digitek® should contact their physician immediately for medical advice.

If you believe that you or a loved one has suffered serious injury or death as a result of taking Digitek®, call us toll free at 1-800-564-4050.

For more information go to http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html