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 and prompted a warning letter from the Food and Drug Administration.
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.
McNeil Consumer Healthcare Products, the unit that manufactures Tylenol 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.
On Friday, the FDA sent McNeil a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way. The way the company handled the recall has irked federal regulators, who say McNeil did not act fast enough.
The FDA said McNeil knew of the problem in early 2008 but made only a limited investigation. 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."
Johnson & Johnson has 15 days to respond to the letter. 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 of nausea.
Johnson & Johnson says the smell is caused by small amounts of a chemical associated with the treatment of wooden pallets. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.
Also on Friday, federal prosecutors in Boston said Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia drug Risperdal.
J&J said in a statement it "will address the government's lawsuit in court" and believes its rebates were "lawful and appropriate."