Recall Issued for Some Children's Tylenol
'Meltaways' and 'SoftChews' Recalled; Design & Label Issues Cited
June 3, 2005 -- The maker of Tylenol has issued a voluntary recall for three
of its products:
- Children's Tylenol Meltaways (80 milligrams)
- Children's Tylenol SoftChews (80 milligrams)
- Jr. Tylenol Meltaways
All lots and flavors of those items packaged in bottles and blisters are
included in the recall. However, no liquid versions of those products are
involved, says Kathy Fallon, director of communications for McNeil Consumer
& Specialty Pharmaceuticals.
The recall stems from design and labeling issues, Fallon tells WebMD.
"There is nothing wrong with the product.
"Some users may become confused by the 'blister' package design and by
some copy on the front label," says Fallon. She says consumers should
"always refer to the drug facts label or the label on the bottle."
"The blister package design, as well as information on the blister
package and on the blister and bottle cartons, may be confusing and could lead
to improper dosing, including overdosing," says a McNeil news release.
"Blister" packages are intended to be convenient for parents who
need dosing flexibility depending on the child's weight or age, says the
release. Some blister "cavities" include one tablet, while others
contain two tablets.
Each children's Tylenol Meltaway and children's Tylenol SoftChew tablet
contains 80 milligrams of the active ingredient, acetaminophen. However, McNeil
says concerns have been raised that some people may mistakenly think that the
two-tablet blister may total 80 milligrams of acetaminophen. Actually, two
tablets would add up to 160 milligrams.
Some Children's Tylenol Meltaways come in bottles packaged in cartons. Some
information on carton fronts may also confuse consumers about proper dosage,
Cartons for Junior Tylenol Meltaways may also be confusing. Consumers should
know that each tablet of junior Tylenol Meltaways contains 160 milligrams
An overdose of acetaminophen may cause liver damage when the product is
taken to relieve fever or pain over the course of the three- or five-day period
specified by the labeling, says McNeil.
The company says it's working with the FDA on the recall and asks consumers
to direct questions to its consumer relationship center at (877) 895-3665 (in
English) or (888) 466-8746 (in Spanish).