In consultation with the US Food and Drug Administration, McNeil Consumer Healthcare, a division of McNeil-PPC, part of Johnson & Johnson (New Brunswick, NJ) is voluntarily recalling certain lots of over-the-counter (OTC) products in the Americas, the United Arab Emirates, and Fiji, according to a J&J press release.
J&J initiated the recall on Jan. 15, 2009, following an investigation of consumer reports of an unusual moldy, musty, or mildewlike odor that, in a small number of cases, was associated with temporary gastrointestinal events such as nausea, stomach pain, vomiting, or diarrhea.
The recalled products include various strengths and dosage forms of Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and Tylenol. The full product recall list may be found here.
McNeil Consumer Healthcare determined that the reported uncharacteristic smell is caused by trace amounts of 2,4,6-tribromoanisole (TBA). The company said that this impurity can result from the breakdown of a chemical that is sometimes applied to wood in pallets that transport and store product-packaging materials. “The health effects of this chemical have not been well studied, but no serious events have been documented in the medical literature,” according to the J&J release.
In December 2009, McNeil Consumer Healthcare also recalled all lots of Tylenol Arthritis Pain 100 count with Ez-Open Cap for the same reason. “McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints,” said J&J in the release. “In addition to the product recall, McNeil Consumer Healthcare is continuing [its] investigation into this issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets.”
McNeil Consumer Healthcare will continue to closely monitor and evaluate the situation and consult with FDA. The company advises consumers who purchased product from the lots included in the recall to stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement.