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Voluntary Recall Announced for Over the Counter Medications

McNeil Consumer Healthcare — makers of Tylenol and many other familiar over the counter medications — announced a voluntary recall of several products on January 15th.

The recall affects certain Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep, and St. Joseph’s products available for purchase in North, South, and Central America, the United Arab Emirates, and Fiji.

Why the voluntary recall? Some consumers reported a strange moldy, musty, or mildewy odor associated with certain products. A small number of consumers reported nausea, stomach pain, diarrhea, or vomiting after using a product with the unusual smell. The symptoms were temporary and not life threatening.

Investigation determined that some of the packaging materials may have been exposed to trace amounts of a chemical called 2,4,6 tribromoanisole (TBA). This chemical comes from the breakdown of another chemical sometimes used on wood pallets — like those used to transport and store packaging materials. The health impact of TBA has not been extensively studied, but there are no reports of major health issues in the research that has been done.

Last month (December 2009), McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100-count with the EZ-open cap for the same reason — reports of a strange smell and the discovery of trace amounts of TBA on the packaging materials.

This new voluntary recall uses broader criteria to identify and remove all product lots that may be affected by the same issue — even if a product has not yet been the subject of consumer complaints.

For more information, call 1-888-222-6036 (Monday through Friday 8am to 10pm EST and weekends 9am to 5pm EST) or visit the website specifically set up for the McNeil product recall. These are the best ways to get information about specific product lots being recalled, how to obtain a refund or replacement, and how to dispose of the contaminated product.

If you have health related concerns or questions, contact your healthcare provider. Adverse reactions may be reported to the U.S. Food and Drug Administration’s MedWatch program.

In order to prevent further problems, McNeil Consumer Healthcare will stop shipment on products produced using materials that were shipped on affected wood pallets. Suppliers have also been asked to discontinue the use of affected wood pallets.