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January 25th, 2010

McNeil Consumer Healthcare Products Recall
A voluntary recall that began in November 2009 with Tylenol Arthritis Pain caplets has been expanded to include more than two dozen other products manufactured by McNeil Consumer Healthcare. The company is initiating this recall following consumer reports of an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events such as nausea, stomach pain, vomiting, or diarrhea. An investigation revealed that the smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). TBA is a breakdown product of a chemical that sometimes is applied to the wood used to build pallets that transport and store product packaging materials. Information about the affected products and lots is available at a dedicated Web site: http://www.mcneilproductrecall.com.

Counterfeit Version of Alli
The Food and Drug Administration is warning consumers about a counterfeit version of Alli (orlistat) 60 mg capsules (120 count refill kit). The counterfeit product contains the controlled substance sibutramine. GlaxoSmithKline has determined that the counterfeit product was sold over the Internet; there is no evidence at this time that counterfeit Alli has been sold through other channels, such as retail stores. Information about identifying counterfeit product is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm.