Actavis Recalls All Lots of Bertek and UDL Laboratories Digitek (digoxin) Tablets
April 25, 2008 - Actavis Totowa LLC, (formerly Amide Pharmaceutical, Inc.) a United States manufacturing division of the generic pharmaceutical company Actavis Group, is initiating a voluntary nationwide Class I recall of Digitek (digoxin) tablets in all strengths. The product is being recalled due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.
Digitek is used to treat heart failure and abnormal heart rhythms. According to the company, 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 illness and injuries have been received.
The products are distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. Consumers are being advised to contact their health care providers if they have any medical questions regarding the recalled Digitek tablets. Do not discontinue any medication without first consulting your doctor.
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