Johnson & Johnson, the US consumer products giant, expanded Friday a Tylenol recall after US federal authorities warned the company was being too slow in dealing with a public health threat.
The expanded recall covers the pain reliever and other over-the-counter drugs sold in the Americas, the United Arab Emirates and Fiji.
AdvertisementMcNeil Consumer Healthcare, a unit of J&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.
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.
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).
"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.
"The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature."
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.
"We sent a warning letter to McNeil for failure to report quality problems," she said.
"McNeil should have acted faster. When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary actions."