UPDATED: Friday, April 13, 2012 - 9:53am
NEW YORK (Reuters) – Johnson & Johnson's consumer division said on Friday it is recalling more than 500 lots of over-the-counter products including Tylenol, Motrin and Rolaids after reports of an unusual odor, expanding on an issue that led to a Tylenol recall last year.
The latest voluntary recall followed 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," the company said. Such events included nausea, stomach pain, vomiting and diarrhea.
The recall involves lots in the Americas, the United Arab Emirates (UAE), and Fiji. In addition to pain relievers Motrin and Tylenol, and the Rolaids antacid, the recall also involved the Benadryl allergy drug and St. Joseph's Aspirin.
J&J's McNeil Consumer Healthcare division said the smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA), which can result from the breakdown of a chemical that is sometimes applied to wood for pallets that transport and store product packaging materials.
A company spokeswoman said it was unclear how the chemical could have penetrated the product packaging.
"The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature," the company said in a statement.
The same chemical has been described in scientific literature as the likely cause of musty or "corked" odors in wines, and linked to wooden storage containers or older structural elements of wineries.
J&J, which also sells prescription drugs and medical devices, is one of the world's largest consumer healthcare companies, with scores of household staples such as Band-Aids and baby shampoo as well as Tylenol.
McNeil Consumer Healthcare in December recalled 52 lots of a form of Tylenol related to the chemical issue. The company said it has now applied broader criteria to identify and remove all product lots that may be affected, even if they have not been the subject of consumer complaints.
McNeil also said it was ceasing shipment of products produced using materials shipped on the wood pallets and requiring suppliers to stop using the pallets.
McNeil, which said it was continuing its investigation, said the recall was being done in consultation with the U.S. Food and Drug Administration.
A J&J spokesman said the financial impact from the two recalls would be recorded in its 2009 results, but it was not considered to be material. The company plans to comment further on the financial ramifications when it reports fourth-quarter results on January 26.
J&J shares were down 35 cents at $64.77 in morning trading on the New York Stock Exchange.