J&J voluntarily recalls certain OTC products

January 22, 2010
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Pharmaceutical Technology Europe

Johnson & Johnson is recalling a number of products because of reports of an unusual mouldy, musty, or mildew-like odour that has been associated with nausea, stomach pain, vomiting or diarrhea in a small number of cases.

Johnson & Johnson is recalling a number of products because of reports of an unusual mouldy, musty, or mildew-like odour that has been associated with nausea, stomach pain, vomiting or diarrhea in a small number of cases. The recall was initiated voluntarily in consultation with the FDA by McNeil Consumer Healthcare, a division of McNeil-PPC, which is part of Johnson & Johnson, for certain lots of OTC products in the Americas, the United Arab Emirates and Fiji, according to a press statement.

The recalled products include various strengths and dosage forms for Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol. The full product recall list may be found here.

McNeil Consumer Healthcare believes that the reported uncharacteristic smell is caused by the presence of trace amounts of 2,4,6-tribromoanisole (TBA). The company explained that the presence of this impurity can result from the breakdown of a chemical that is sometimes applied to wood 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,” said the J&J release.

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,” said J&J in the release. “In addition to the product recall, McNeil Consumer Healthcare is continuing 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 says it will continue to closely monitor and evaluate the situation and consult with the 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.

www.jnj.com