Tylenol maker in hot water with the FDA

From ABC News:

The U.S. Food and Drug Administration slammed Tylenol manufacturer McNeil Healthcare LLC during a media briefing this morning for what it called a slow response to problems at a facility in Puerto Rico that led to consumers becoming sickened by tainted pills.“McNeil should have acted faster,” said Deborah Autor, director of the FDA’s Office of Compliance, of the arm of Johnson & Johnson that manufactures Tylenol products, adding “When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem.”

A recall of Tylenol products that began last month with the popular Tylenol arthritis caplet expanded this morning to include more than two dozen other over-the-counter products manufactured by McNeil.

The broadened directive adds 54 million bottles of product to the recall, boosting the total number of bottles recalled by McNeil to 60 million, according to the company.

McNeill initiated a voluntary recall of Tylenol Arthritis Relief Caplets at the end of December after consumer complaints of stomach problems. The problems were linked to the presence of a chemical called 2,4,6-tribromoanisole (TBA), which results from the breakdown of a chemical in wood pallets used to transport and store packaging materials for the drugs.

Now it appears that the problem extended into other Tylenol products as well, according to the FDA.

Tylenol Extra Strength, Rolaids and a number of children’s medicines are now included in the recall, which affects 27 products in various packaging quantities.

Continue reading FDA slams Tylenol maker’s delay in tainted pill recall

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