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Reviewed By Laura J. Martin, MD
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 FDA.
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 medications.
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 theoretical concerns."
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, she says.
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.
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Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research, FDA.
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