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Digitek Recalled Due to Possible Dosage Issue
Source: The Food and Drug Administration Digitek, a drug used to treat heart failure and abnormal heart rhythms, has been voluntary recalled due to the possibility of tablets being abnormally thick and contain twice the approved level of active ingredient. This Class I nationwide recall is on all lots and all strengths of Digitek (under the Bertek and UDL labels). Patients using this double strength medication, specifically those with kidney failure, are at risk for digitalis toxicity or could be potentially fatal. Symptoms of digitalis toxicity include nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Please note that you can find information about how to return your prescription drug product(s) by contacting Stericycle customer service at 1-888-276-6166. Representatives are available Monday through Friday from 8 a.m. to 5 p.m. If you currently use Digitek, please contact your physician immediately with questions. Read the complete 2008 MedWatch Safety Summary, including information on how to return the products at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Digitek |
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