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Johnson & Johnson Unit Gets Warning Letter Over Musty Tylenol Recall

Jan 18, 2010

It looks like Johnson & Johnson is in trouble over its recent recall of  Tylenol and other over-the-counter drugs that were associated with a musty odor and stomach illness among users.

According to a report in the Los Angeles Times, the Food & Drug Administration (FDA) thinks Johnson & Johnson's McNeil Consumer Healtcare unit should have acted sooner to deal with the odor issue. 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.

According to the Times, 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.

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.

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