1. Product Recall  What: Children’s TYLENOL Meltaways and Softchews Tablets  Recall Date: June 3, 2005  Why: The labeling on the 80 mg Meltaways and Softchews tablets could be misleading and could suggest to take more than the recommended dosage. Which could lead to an over-dose for small children.  Incidents: This was a voluntary recall to avoid possible health risks and no incidents were reported. If the drug was not recalled, taking too much acetaminophen could lead to liver damage.  All lots were recalled nationwide: approximately 186,000 units ETM591 Hunter King

2. Management Issues  Recognition of Problem: Parents would call Tylenol company saying they were confused on the proper dose to give to their children. Each tablet has the proper dose of 80 mg of Acetaminophen, but the blister packs that stored the tablets contained two tablets per compartment. If the parent gave the children both tablets per compartment it could over-dose the child.  Speed of Response: The recall was issued in June but the concerns became known in March. It was also unclear as to the number of units that were affected by the mislabeling.  Responsibility: The makers of Tylenol is responsible who is in association with the McNeil Consumer and Specialty Pharmaceuticals. This pharmaceutical company is a subdivision of Johnson & Johnson, Inc. ETM591 Hunter King

3. Impact of Recall  Legal Consequences: Since the recall happened fast enough without any fatal accidents, there were no lawsuits or any other monetary compensation. The labels on container and blister packs were given more explanation in detail as to the proper amount needed to take.  Reputation: This recall caused no adverse publicity to Tylenol. However, some other recalls issued by Tylenol have caused bad publicity from the public.  Sales: According to the New York Stock Exchange, the company Johnson & Johnson suffered a minor decline in sales during that time period from June 2005 to September 2005. This recall of Tylenol children’s tablets may be a contributor to the decline in sales. ETM591 Hunter King

4. References (1) Food and Drug Administration, Enforcement Report For July 20,2005, http://www.fda.gov/Safety/Recalls/EnforcementReports/2005/ucm120359.ht m http://www.fda.gov/Safety/Recalls/EnforcementReports/2005/ucm120359.ht m (2) Food and Drug Administration, Medwatch Safety Alerts for Human Medical Products http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHum anMedicalProducts/ucm150951.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHum anMedicalProducts/ucm150951.htm (3) New York Stock Exchange, Johnson and Johnson Inc. http://www.google.com/finance?q=NYSE:JNJ (4) Hechtkopf, Kevin (2005) CBSNews Healthwatch, Some Children’s Tylenol Recalled (5) The associated press (June 4, 2005) New York Times, Tylenol Maker Recalls Children’s Products ETM591 Hunter King