Actavis Digitek Recall Campaign

Actavis Digitek Recall Campaign - Actavis Digitek Recall...

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Click to edit Master subtitle style 5/17/11 CAP 320 Indy Case Study Actavis Digitek Recall Campaign
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5/17/11 Digitek Recall 2008 April 25, 2008 – Actavis Totowa L.L.C. initiated a class I nationwide recall on all strengths for oral use of the drug Digitek. Recall was issued due to tablets containing twice the levels of active ingredient digitalis. Consumers taking twice the recommended dose of Digitek can be subjected to Digitek toxicity.
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5/17/11 What is Digitek? Prescription drug used to treat: Heart failures Abnormal heart rhythms Treats heart pain May be used after a heart attack Prescribed to adults, children, and even pets. Manufactured by two distributors: Mylan Pharmaceuticals (under the label “Bertek Digitek”) UDL Laboratories (under label “UDL Digitek”)
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5/17/11 Side Effects of Digitek Toxicity Common Side Effects Abdominal pain Adverse cardiac effects Confusion and mental disturbances (i.e. hallucinations, anxiety, delirium, depression) Dizziness Gynecomastia (enlargement of male breasts) Nausea and vomiting Low platelet count in blood (causing an increase risk of bleeding) Visual disturbances (blurred or yellow vision) More Severe Side Effects Abnormally Slow Heart Rate
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5/17/11 Past Health Concerns of Digitek February 1992 – September 2002: Former nurse and serial killer, Charles Cullen, used the drug to overdose and kill 17 of his patients in New Jersey and Pennsylvania hospitals. January 2006 – FDA’s review of Actavis found potentially and unexpected adverse drug experiences for several of their products, including Digitek. (Actavis did not report these drug experiences to FDA). August 15, 2006 – FDA issued warning letter to Actavis acknowledging the company’s failure to file periodic safety reports of its New Jersey plant where Digitek was manufactured.
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5/17/11 How did Actavis handle this recall Company took few steps toward implementing a crisis response plan toward the issue. Directed customer inquiries related to the issue to Stericycle customer services and provided a phone number and representative hours. 1-888-276-6166 Monday thru Friday 8:00 a.m. thru 5:00 p.m., EST. Information about the recall could be found on Actavis U.S. website.
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This note was uploaded on 05/16/2011 for the course CAP 321 taught by Professor Professorwalz during the Spring '11 term at Grand Valley State University.

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Actavis Digitek Recall Campaign - Actavis Digitek Recall...

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