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Chicago TribuneJohnson & Johnson criticized in Tylenol recallFDA accuses drugmaker of dragging its feet in recall of tainted Tylenol, Motrin and other over-the-counter medicationsChicago Tribune
By Andrew Zajac Tribune Newspapers
January 16, 2010WASHINGTON - Johnson & Johnson's McNeil Consumer Healthcare Products division expanded its recall of various batches of Tylenol, Motrin and other over-the-counter products tainted by a chemical in wooden shipping pallets, and it came under fire Friday from the Food and Drug Administration, which said the company dragged its feet in investigating the contamination and pulling goods from store shelves.
Consumers have complained of moldy-smelling bottles, and some have been temporarily sickened with nausea, vomiting, diarrhea or other stomach distress, said Deborah Autor, head of compliance in FDA's drug office. "McNeil should have acted faster," Autor said. "When something smells bad, literally and figuratively, companies must take all necessary actions" to fix the problem.
Autor said McNeil realized it had a problem with products in September 2008 but didn't notify the FDA until the following September and didn't begin recalling products until November. The FDA cannot order product recalls on its own. The FDA on Friday sent McNeil a warning letter seeking improvements in the company's manufacturing operations.
McNeil has linked the illness to 2,4,6-tribromoanisole, a chemical used to treat pallets that contained packaging material used in the tainted products. Investigators surmise that the chemical leached into the packaging material.
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http://www.chicagotribune.com/business/chi-tc-biz-johnson-0115-0116-jan16,0,6213281.story
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