Product Recall

1
Product Recall

• What Childrens 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

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.

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 childrens tablets may be a contributor
  to the decline in sales.

4
References

• (1) Food and Drug Administration, Enforcement
  Report For July 20,2005, http//www.fda.gov/Safety
  /Recalls/EnforcementReports/2005/ucm120359.htm
• (2) Food and Drug Administration, Medwatch
  Safety Alerts for Human Medical Products
  http//www.fda.gov/Safety/MedWatch/SafetyInformati
  on/SafetyAlertsforHumanMedicalProducts/ucm150951.h
  tm
• (3) New York Stock Exchange, Johnson and Johnson
  Inc.
• http//www.google.com/finance?qNYSEJNJ
• (4) Hechtkopf, Kevin (2005) CBSNews Healthwatch,
  Some Childrens Tylenol Recalled
• (5) The associated press (June 4, 2005) New York
  Times, Tylenol Maker Recalls Childrens Products