Johnson & Johnson Issues Massive Recall of Tylenol - ABC News

Johnson & Johnson Issues Massive Recall of Tylenol - ABC News

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.
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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.
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"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." ...