FDA: Manufacturing Problems Led to Tylenol Recall
FDA Says McNeil Plant Didn't Test Properly for Contamination of Kids' Tylenol, Motrin, Zyrtec
May 4, 2010 -- Deficient manufacturing practices at the plant involved in
the recent recall of infant and children's Tylenol, Motrin, Zyrtec, and
Benadryl products may be responsible for bacterial contamination of raw
materials in the recalled products, according to a new report issued by the
The report is based on a recent inspection of the McNeil Consumer Healthcare
plant in Fort Washington, Pa. McNeil is a division of Johnson & Johnson.
This is the only McNeil plant that produces the infant and children's liquid
The sweeping recall affected 43 child and infant liquid formulations of
Tylenol, Motrin, Zyrtec, and Benadryl.
In the new report, the FDA cited more than 20 manufacturing problems,
including not properly testing for contamination of the recalled products. The
report also stated that the company did not initiate "corrective and prevention
action" after receiving some 46 consumer complaints from June 2009 to April
2010 regarding foreign materials in the products.
The FDA is preparing a full report based on these findings.
The violations are "serious," but the FDA can't yet say whether any further
actions are warranted, says Deborah M. Autor, director of the Office of
Compliance at the FDA's Center for Drug Evaluation and Research. The company
has taken some actions to correct and improve the situation, but whether or not
these actions are sufficient is also not known yet, she says.
Autor called any actual risk to children who use these products "remote"
during a telephone briefing.
"The problems we have actually seen in products in the market are ones that
we do not believe will cause a significant medical concern," she says. "We have
But "consumers should not use these products -- and by all means, they
should look for generic versions," says Autor. "Do not use products for infants
or children that are not intended for their age groups."
There is no reason to suspect that generic versions would be contaminated,
Johnson & Johnson called the problems "unacceptable to us, and not
indicative of how McNeil Consumer Healthcare intends to operate" in a statement
to the media. Production at this plant will stop until the problems are
corrected, according to the statement.