Smelly Tylenol Recall Delayed, FDA Charges

Johnson & Johnson is taking heat from federal regulators over its recent recall of <"">Tylenol and other over-the-counter drugs. According to a report in the Los Angeles Times, the Food & Drug Administration (FDA) has sent Johnson & Johnson unit McNeil Consumer Healthcare a warning letter for taking too long to issue the recall.

In November, McNeil recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP because of reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea. That recall was expanded in December to include all lots of the product. Last week, the list of recalled drugs was expanded yet again to include various lot of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. The expanded recall includes about 50 million bottles of the medications.

McNeil blamed the foul odor on contamination by a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, but McNeil said that so far, to date all of the reported adverse reactions have been temporary and non-serious.

According to the Los Angeles Times report, the FDA thinks McNeil should have acted sooner to deal with the odor issue. Deborah Autor, chief of compliance in FDA’s drug office, said that McNeil knew about the problem in September 2008, but only let the agency know in September 2009. The FDA does not have the authority to order a drug maker to issue a recall.

Because of the delay, the FDA has sent a warning letter to the company detailing manufacturing violations and quality problems. The letter charges that McNeil did not conduct a timely, comprehensive investigation, did not quickly identify the source of the problem, and did not notify authorities in a timely fashion, prolonging consumer exposure to the products.

“McNeil should have acted faster,” Autor said during a conference call with reporters on Friday. “When something smells bad, literally and figuratively, companies must take all necessary actions.”

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