Activas Recall Campaign

Activas Recall Campaign - Running head: Actavis Digitek...

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Running head: Actavis Digitek Recall 1 READ FOR CONTENT = APA MAY NOT BE CORRECT Actavis Digitek Recall Campaign CAP 320 Student Grand Valley State University
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Actavis Digitek Recall 2 Situation Analysis Digitek Recall 2008 On April 25, 2008, Actavis Totowa L.L.C., a United States manufacturing division of the international generic pharmaceutical company of Actavis Group, initiated a Class I nationwide recall on all strengths for oral use of the drug Digitek. The recall was issued because the tablets contained twice the levels of the active ingredient digitalis. Consumers taking more than twice the recommended and safe level of Digitek can be subjected to Digitek toxicity (Actavis 2, 2008). Digitek is a prescription drug used to treat heart failures, abnormal heart rhythms, and can be used to treat heart pain and may be used after a heart attack. The drug was used to treat children, adults, and even pets. This generic drug is manufactured by two distributors, Mylan Pharmaceuticals, under the label “Bertek Digitek” and UDL Laboratories, under the label “UDL Digitek”(Actavis 2, 2008).
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Actavis Digitek Recall 3 Common side effects of Digitek toxicity that consumers noticed were, abdominal pain, adverse cardiac effects, confusion and mental disturbances (such as hallucinations, anxiety, delirium, and depression), diarrhea, dizziness, gynecomastia (enlargement of male breasts), hemorrhagic necrosis of the intestines, a maculopapular rash (flat, red areas on the skin covered with small bumps similar to measles), nausea and vomiting, thrombocytopenia (low platelet count in the blood, making an increased risk of bleeding), and visual disturbances (blurred or yellow vision). More severe side effects of Digitek toxicity are bradycardia (abnormally slow heart rate), cardiac instability, low blood pressure, and even death. Knowing these side effects, it is apparent that this recall was not something to be taken lightly and handled in a poor manner (US Recall News, 2008). It was not just in April of 2008 that the company Actavis had encountered problems with this drug that sparked health concerns for consumers. The first problem recorded for this drug was in February 1992 thru September 2002. During this time, Charles Cullen, a former nurse and infamous serial killer in New Jersey history was overdosing his patients with the drug. Cullen killed 17of his patients with Digitek in New Jersey and Pennsylvania hospitals. In January 2006, the Federal Drug Administration’s review of Actavis found potentially and serious unexpected adverse drug experiences dating back to the year 1999 for several of its products, including Digitek. Actavis did not report these unexpected adverse drug experiences to the FDA. Then, on August 15, 2006, the FDA issued a warning letter to Actavis acknowledging the company’s failure to file periodic safety reports of its New Jersey facility, where Digitek is manufactured. This failure violated Actavis obligation to report adverse medical events and led to the improper
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Activas Recall Campaign - Running head: Actavis Digitek...

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