NEW YORK — Johnson & Johnson expanded a recall of over-the-counter medications Friday, the second time it has done so in less than a month, because of a moldy smell that has made users sick.
The broadening recall now includes some batches of regular and extra-strength Tylenol, children's Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl, Rolaids, Simply Sleep and St. Joseph's aspirin. Caplet and geltab products sold in the Americas, the United Arab Emirates and Fiji were recalled.
Johnson & Johnson's McNeil Consumer Healthcare Products recalled some Tylenol Arthritis Caplets in November due to the smell, which caused nausea, stomach pain, vomiting and diarrhea. Almost three weeks ago, the company expanded its recall to include Tylenol Arthritis Caplets.
The way the company handled the recall has irked federal regulators, who say McNeil did not act fast enough.
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The Food and Drug Administration said McNeil knew of the problem in early 2008 but made only a limited investigation.
The FDA cannot order product recalls on its own authority.
The agency said about 70 people were either sickened by the odor, or noticed it.
"McNeil should have acted faster," said Deborah Autor, the director of the FDA's Office of Compliance of the Center for Drug Evaluation and Research. "When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem."
The FDA sent McNeil a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way, Autor said.
Johnson & Johnson has 15 days to respond. The FDA says it wants an explanation as to why the problem was not made public sooner.
There have been no reports of nausea related to the most recent recall, the company said.
McNeil, however, said the expanded recall includes product lots that could be affected by the same problems. A full list of the recalled products is online at www.mcneilproductrecall.com.
McNeil has linked the illness to 2,4,6-tribromoanisole, sometimes called TBA, a chemical used to treat pallets that held packaging material used in the tainted products. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.
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.
The New Brunswick, N.J., company said it is investigating the issue and will stop shipping products with the same materials on wooden pallets. It has asked suppliers to do so as well.
The company said it is working with the Food and Drug Administration.