Digitek Digoxin Recall

Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient

On April 25, 2008 the FDA issued a press release alerting the public to a Class I recall of digoxin made by Digitek. These digoxin tablets had been produced at double-strength for months, causing many patients to overdose from digoxin toxicity.

Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.

DigitekR is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis 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 illnesses and injuries have been received.

Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia. Bradycardia is a slower than normal heartbeat rate. Vision changes such as halos or light rings around objects, seeing lights and bright colors, experiencing changes in color perception, blind spots in vision, and blurred vision can also occur. Patients can also experience decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down. At its most severe, death can result from excessive Digitalis intake. There have been several reports of illness and injuries related to the recalled medications.

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