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MCNEIL CONSUMER HEALTHCARE ANNOUNCES
VOLUNTARY RECALL OF
CERTAIN OVER-THE-COUNTER (OTC) PRODUCTS IN
THE AMERICAS, UAE,
AND FIJI
In consultation with the U.S. Food and Drug Administration
(FDA), McNeil Consumer
Healthcare, Division of McNEIL-PPC, Inc.,
is voluntarily recalling certain lots of OTC
products in the Americas, the United Arab
Emirates (UAE), and Fiji. The company is
initiating this recall following an
investigation of consumer reports of an unusual moldy,
musty, or mildew-like odor that, in a small
number of cases, was associated with
temporary and non-serious gastrointestinal
events. These include nausea, stomach
pain, vomiting, or diarrhea. This
precautionary action is voluntary and has been taken
in consultation with the FDA.
Based on this investigation, McNeil
Consumer Healthcare has determined that the
reported uncharacteristic smell is caused
by the presence of trace amounts of a
chemical called 2,4,6-tribromoanisole (TBA).
This can result from the breakdown of a
chemical that is sometimes applied to wood
that is used to build wood pallets that
transport and store product packaging
materials. The health effects of this chemical
have not been well studied, but no serious
events have been documented in the medical
literature. A small number of the product
lots being recalled were associated with the
complaints of an unusual moldy, musty, or
mildew-like odor, and some of these lots
were found to contain trace amounts of TBA.
In December 2009, McNeil Consumer
Healthcare also recalled all lots of
TYLENOL® Arthritis Pain 100 count with EZ-OPEN
CAP related to this issue. McNeil Consumer
Healthcare has now applied broader criteria
to identify and remove all product lots
that it believes may have the potential to be
affected, even if they have not been the
subject of consumer complaints.
In addition to the product recall, McNeil
Consumer Healthcare is continuing their
investigation into this issue and is taking
further actions that include ceasing shipment
of products produced using materials
shipped on these wood pallets and requiring
suppliers who ship materials to our plants
to discontinue the use of these pallets. We
will continue to closely monitor and
evaluate the situation and consult with the FDA.
Consumers who purchased product from the
lots included in this recall should stop
using the product and contact McNeil
Consumer Healthcare for instructions on a refund
or replacement. For these instructions or
information regarding how to return or dispose
of the product, consumers should log on to
the internet at
www.mcneilproductrecall.com
or call 1-888-222-6036 (Monday-Friday 8
a.m. to 10 p.m. Eastern Time, and Saturday-
Sunday 9 a.m. to 5 p.m. Eastern Time).
Consumers who have medical concerns or
questions should contact their healthcare
provider. Any adverse reactions may also be
reported to the FDA's MedWatch Program by
fax at 1-800-FDA-0178, by mail at
MedWatch, FDA, 5600 Fishers Lane,
Rockville, MD 20852-9787, or on the MedWatch
website at
www.fda.gov/medwatch.
The affected product lot numbers for the
recalled products can be found on the side of
the bottle label.
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