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Tylenol Recall in Effect Includes Several Other Drugs

HealthDay News
by -- Andrea Mongler
Updated: Jan 20th 2010

 

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WEDNESDAY, Jan. 20 (HealthDay News) -- McNeil Consumer Healthcare has recently expanded its voluntary recall of some over-the-counter drugs to include about 500 lots of products, according to officials from the Office of Compliance in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.

McNeil, a Johnson & Johnson subsidiary, started its recall in September, and at the time it was limited to certain lots of Tylenol. The company expanded the recall in December and again last week, and it now includes certain lots of Motrin, Benadryl, Rolaids and St. Joseph aspirin.

The recall is a response to an uncharacteristic moldy, musty or mildew-like odor reported by consumers. In a small number of cases, the odor was associated with gastrointestinal events, including nausea, stomach pain, vomiting and diarrhea. McNeil has determined that the odor is caused by trace amounts of the chemical 2,4,6-tribromoanisole, which is used to treat the wooden pallets on which the drugs' packaging material is transported and stored.

"The health effects of this chemical have not been well-studied, but no serious events have been documented in the medical literature," said Deborah M. Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research at the FDA, during a Jan. 15 news conference.

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