Class 1 Recall of Digitalis

The Food and Drug Administration (FDA) today issue a press release for Actavis Totowa LLC. The manufacturer located in Morristown, NJ has issued a Class 1 recall of all strengths of their digitalis tablets manufactured under the name Digitek. Distribution of the defective products is by Mylan Pharmaceuticals using their Bertek label, and by UDL Laboratories using their UDL label.

The digitalis tablets came out of manufacturing with a double thickness of the tablet, meaning each tablet is a double-dose of the medication. Since Digitek is taken to correct abnormal heart rates and for heart failure, the double-dose poses quite a risk as well digitalis toxicity which can cause renal failure. The symptoms of excess Digitek in the system can be nausea, vomiting, dizziness, low blood pressure, cardiac instablity and bradycardia (abnormally slow heart rate).

Patients taking either of these medications should contact Stericycle, a pharmaceutical recall service company, at 1-888-276-6166 and contact their medical providers immediately.



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