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Old 29-05-2004, 01:34 AM
Duckie ®
 
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Default McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide Consumer Alert of Children's Motrin Grape Chewable Tablets

McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide
Consumer Alert of Children's Motrin Grape Chewable Tablets
Contact: Kathy Fallon 215-273-7818
Ami Schmitz-Levine 215-273-8162

FOR IMMEDIATE RELEASE -- Fort Washington, PA -- May 12, 2004 -- McNeil
Consumer & Specialty Pharmaceuticals is alerting consumers that one
manufacturing lot (Lot # JAM108, exp 1/06) of Children's Motrin
(ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol
8-Hour® extended release (acetaminophen) Geltabs. Lot # JAM108 was
distributed nationwide to wholesale and retail customers between
February 5 and April 1, 2004. The bottles are labeled as containing 24
tablets.

The Tylenol 8-Hour product provides an adult dose of acetaminophen,
and use of this adult product could provide more than the recommended
dose (overdose) for children. The mislabeled bottles appear to be the
result of a packaging error for this one lot. To date, two mislabeled
bottles have been identified but no injuries have been reported as a
result of this issue. In the interest of patient health and safety,
McNeil, in consultation with the U.S. Food and Drug Administration, is
taking the precaution of alerting consumers nationwide about this
issue to help them identify the potentially affected product. McNeil
has also alerted retailers nationwide.

The two medicines are visibly different. Children's Motrin Grape
Chewable Tablets are round, purple-colored, scored tablets with the
letters MO and the number 50 on the tablet surface. These tablets have
a non-glossy finish and a grape smell. The Tylenol 8-Hour Geltabs are
hard, round, gelatin coated and shiny. The geltabs are white on one
side, red on the other, with "8 Hour" printed in blue on either the
red or the white side.

Consumers can identify the manufacturing lot number that is embossed
on the carton end flap, and printed on the bottle label under McNeil's
address as "Exp 1/06 JAM108". Anyone identifying one of the bottles
included in this consumer alert should contact McNeil's Consumer
Relationship Center at 1-800-962-5357. Parents who believe their
children may have taken Tylenol 8-Hour Geltabs, believing them to be
Children's Motrin Grape Chewable Tablets, should contact their health
care provider or a poison control center immediately

For more information on this consumer alert, or to report an adverse
event, please call McNeil's Consumer Relationship Center at
1-800-962-5357.

McNeil continues to be committed to the integrity of its products and
the health and safety of the patients who use its products.

####



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