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With Tylenol recall 2010, a corporate icon stumbles

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To be fair, Johnson & Johnson's current problems are far less severe than in 1982. The effects of the tainted drugs have been uncomfortable but not lethal. There's no killer this time running around injecting Tylenol tablets with cyanide.

What's embarrassing about the latest recall is that it took so long for the company's business unit, McNeil Consumer Healthcare, to detect the problem and act.

"While McNeil has cooperated with FDA in recent weeks, there initial response was unsatisfactory," says Christopher Kelly, an FDA press officer. "We repeatedly pressed them."

For example: In 2008, starting in May, the company received 76 consumer complaints about a musty odor emanating from some of its Tylenol products, according to a detailed FDA investigator's report (.pdf) filed last week. But the company didn't test for the problem until September of that year and only tested the drugs and the packaging, not the factory environment, the inspector reported.

Other waves of complaints cropped up the following April, June, and August, according to the report, but the company didn't issue an alert until September, didn't investigate other batches of Tylenol, and didn't initiate a recall until November.

Probable cause: wooden pallets

By mid-December, two company investigations had concluded that the most probable cause of the problem was chemically treated wood from pallets and empty bottles coming from the bottle manufacturer, the FDA report said. McNeil expanded its recall on Dec. 18 to include all lots of a Tylenol arthritis product with a red easy-open cap.

But again, the company failed to assess other medicines using packaging material from the same supplier, according to the FDA report, despite more than 10 complaints of mustiness for its Rolaids product and more than 39 similar complaints for another Tylenol product.

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