By MARLEY SEAMAN, AP Health Writer Marley Seaman, Ap Health Writer – Sat Jan 16, 1:10 am ET
NEW YORK – Johnson & Johnson issued a massive recall Friday of over-the-counter drugs including Tylenol, Motrin and St. Joseph's aspirin because of a moldy smell that has made people sick.
It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008. Federal regulators criticized the company, saying it didn't respond to the complaints quickly enough, wasn't thorough in how it handled the problem and didn't inform the Food and Drug Administration quickly.
The recall 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.
The FDA and Johnson & Johnson's McNeil Consumer Healthcare Products said they did not know the number of bottles recalled. It included caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji.
Consumers should check the full list at http://us.rd.yahoo.com/dailynews/ap/ap_on_bi_ge/storytext/us_johnson___johnson_tylenol_recall/34750619/SIG=1144vpchf/*http://www.mcneilproductrecall.com to identify the recalled batches.
The FDA said about 70 people have been either sickened by the odor — including nausea, stomach pain, vomiting and diarrhea — or noticed it.
The smell is caused by small amounts of a chemical associated with the treatment of wooden pallets, Johnson & Johnson said. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.
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 FDA said McNeil knew of the problem in early 2008 but made only a limited investigation.
"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.
In November, McNeil recalled some Tylenol Arthritis Caplets due to the smell. Almost three weeks ago, the company expanded its recall to include more batches of Tylenol Arthritis Caplets.
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.
The company said it is working with the FDA.
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.
The government's complaint states that J&J gave special rebates to Omnicare Inc., the country's biggest dispenser of prescription drugs to nursing homes, in return for recommendations from its pharmacists that patients be given Risperdal, in many cases when it was inappropriate.
J&J said in a statement it "will address the government's lawsuit in court" and believes its rebates were "lawful and appropriate."