FDA scolds maker of Tylenol for foot-dragging in recall
As McNeil Consumer Healthcare Products expanded its recall of various batches of Tylenol, Motrin and other over-the-counter products tainted by a chemical in wooden shipping pallets, the company today came under fire from the Food and Drug Administration for dragging its feet in investigating the contamination and pulling goods from store shelves.
“McNeil should have acted faster,” said Deborah Autor, chief of compliance in FDA’s drug office. “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 September 2009 and didn’t begin recalling products until November.
The FDA cannot order product recalls on its own authority.
As a result of the delays, the FDA today sent McNeil a warning letter seeking improvements in the company’s manufacturing operations.
Consumers have complained of moldy-smelling bottles, and some have been temporarily sickened with nausea, vomiting, diarrhea or other stomach distress, according to Autor, who spoke on a conference call with reporters.
McNeil, a division of Johnson & Johnson, has linked the illness to 2,4,6-tribromoanisole, sometimes called TBA, 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.
TBA has not been well-studied for its effects on human health, but is not believed to cause serious illness, Autor said.
A full list of recalled products is available at mcneilproductrecall.com.
