Expanded Tylenol Recall Includes Children's Medications

Filed under: In The News

The FDA says the company should have acted faster. Credit: McNeil Consumer Healthcare

Executives at Johnson & Johnson announced an expanded recall that includes children's Tylenol and Motrin as well as other medications Friday.

This is the second time in less than a month that company officials have announced a recall in response to reports of a moldy smell that has made customers sick.

Other brands include Benadryl, Rolaids, Simply Sleep, Motrin IB, St. Joseph's aspirin as well as regular, extra strength and eight-hour Tylenol. Tylenol PM and Tylenol for arthritis are also affected by the recall.

The recall covers caplets and geltabs sold in the United States, United Arab Emirates and Fiji.

Tylenol products were recalled 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.

Federal regulators say company executives did not act fast enough. Officials at the Food and Drug Administration tell ABC News that executives knew of the problem in early 2008 but made only a limited investigation.

ABC News reports at least 70 people were either sickened by the odor or noticed it.

The company "should have acted faster," Deborah Autor, the director of the FDA's Office of Compliance of the Center for Drug Evaluation and Research, tells ABC News. "When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem."

FDA officials sent the company a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way, Autor tells ABC. Executives had 15 days to respond. Autor tells ABC the FDA 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, company execs report. However, they add that products in the expanded recall could be affected by the same problem as the earlier batch because of a a chemical associated with the treatment of wooden pallets.

FDA officials tell ABC News the chemical can leach into the air. They traced it to a facility in Las Piedras, Puerto Rico.

Company executives tell ABC they are investigating the issue and will stop shipping products with the same materials on wooden pallets.

Also on Friday, federal prosecutors in Boston claim company execs paid tens of millions of dollars in kickbacks so nursing homes would put more patients on their schizophrenia drug.

ABC reports the company allegedly gave special rebates to Omnicare Inc., the country's biggest company providing pharmacy services to nursing homes, in return for recommendations from its pharmacists that patients use Risperdal.

Related: Protecting Your Kids From Colds and Flu

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