FORT WASHINGTON, Pa. McNeil Consumer Healthcare on Friday announced a voluntary recall of certain lots of over-the-counter products in the Americas, the United Arab Emirates and Fiji.
The company is initiating this recall following an investigation of 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. These include nausea, stomach pain, vomiting or diarrhea. The precautionary action is voluntary and has been taken in consultation with the Food and Drug Administration.
Based on its investigation, McNeil Consumer Healthcare has determined that the reported uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood 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. A small number of the product lots being recalled were associated with the complaints of an unusual moldy, musty, or mildew-like odor, and some of these lots were found to contain trace amounts of TBA.
In December 2009, McNeil Consumer Healthcare also recalled all lots of Tylenol Arthritis Pain 100 count with EZ-OPEN CAP related to this issue. 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.
In addition to the product recall, McNeil Consumer Healthcare is continuing their investigation into that 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. The company stated it will continue to closely monitor and evaluate the situation and consult with the FDA.
The impacted brands include Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.