J&J expands Tylenol recall after FDA warning
AFP Global Edition | 2010-01-15 21:10:51
<div><p>Johnson &amp; Johnson, the US consumer products giant, expanded Friday a Tylenol recall after US federal authorities warned the company was being too slow in deal with a public health threat.</p><p>The expanded recall covers the pain reliever and other over-the-counter drugs sold in the Americas, the United Arab Emirates and Fiji.</p><p>McNeil Consumer Healthcare, a unit of J&amp;J, said it was voluntarily recalling about 500 lots of the products, which include pain relievers Tylenol, Motrin and St. Joseph, a children's aspirin.</p><p>The company already had recalled in December all lots of a type of Tylenol product in response to consumer complaints of a foul odour that in some cases had prompted "non-serious" gastrointestinal disorders including vomiting and diarrhea.</p><p>McNeil said an investigation had shown the "unusual moldy" odour is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).</p><p>"This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials," the company said.</p><p>"The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature."</p><p>Deborah Autor, director of the FDA's compliance office on drugs, told reporters Friday that the federal agency had warned McNeill that it had mishandled the problem.</p><p>"We sent a warning letter to McNeil for failure to report quality problems," she said.</p><p>"McNeil should have acted faster. When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary actions."</p><img src="http://admatch-syndication.mochila.com/images/ad.gif?aid=66988157&bid=informcom" /></div><div id="copyright"><div>
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