FDA: JNJ Unit Failed To Test Tylenol For Contaminants
January 13 2010 - 7:07PM
Dow Jones News
A Johnson & Johnson (JNJ) unit failed to test whether its
pain reliever Tylenol was chemically contaminated despite receiving
a heightened number of consumer complaints in 2008 that the pills
smelled musty, according to a report by U.S. Food and Drug
Administration inspectors.
In 2008, J&J's McNeil Consumer Healthcare received more than
70 musty odor complaints for Tylenol Arthritis Caplets. However,
the company didn't conduct a formal investigation at the time even
though more than eight of the complaints suggested the pills caused
gastrointestinal problems in patients, the FDA report says.
The report says the company did physically examine whether the
moldy odor originated from the presence of microorganisms and
concluded it didn't.
McNeil spokeswoman Bonnie Jacobs said the company has received
the FDA report and "is actively working in consultation with the
FDA to address their concerns." She said the company wouldn't
answer other questions at this time.
In early November McNeil said it was voluntarily recalling
certain lots of Tylenol Arthritis Pain Caplet 100 count bottles
after receiving consumer complaints that the product caused nausea
and other symptoms. A month later the company expanded the recall
to include all Tylenol Arthritis Caplet 100-count bottles, and said
the odor was likely caused by chemically treated wood pallets being
located near where the medicine is packaged.
FDA investigators inspected McNeil's Las Piedras, Puerto Rico
plant from October 2009 through Jan. 8, 2010. After an inspection,
FDA investigators present companies with report that details their
findings. The report, posted to the FDA's Web site Wednesday, notes
the company initiated the recall during the inspection.
The FDA says the company doesn't properly follow protocols for
handling consumer plants. "For example, your firm received multiple
uncharacteristic-smell consumer complaint reports since May 2008,
but the trend was not detected until August 2008," according to the
report.
The report also says the company didn't assess whether
chemically treated wood pallets also caused moldy odor in its
heartburn medicine Rolaids. The FDA said consumers have filed more
than 10 complaints of moldy-smelling Rolaids.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com
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