Transcript 2003Product Recall_King_Tylenol

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
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
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
References
(1) Food and Drug Administration, Enforcement Report For July 20,2005,
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
(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