Tylenol Recalled Again for Moldy Odor

Oct. 19, 2010
Johnson & Johnson’s McNeil Consumer Healthcare unit is recalling a product lot of TYLENOL 8 Hour caplets 50 count bottles to the retail level after receiving complaints of a musty or moldy odor.  This is the 13th in a series of recalls by the company over the past year. MH&L (then known as Material Handling Management) wrote a series of reports on this problem, placing special emphasis on suspected links to the wooden pallets used to transport these products.

Subsequently McNeil linked the odor to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This is produced by the conversion of its precursor, 2,4,6 tribromophenol (TBP), a wood preservative that has been linked to the pallets used to carry J&J’s products. However, in correspondence to executives at McNeil and Johnson & Johnson, the National Wooden Pallet and Container Association (NWPCA) demanded definitive evidence that the source of the contamination was TBA, as well as “technical and scientific theory as to how this chemical could spread from a tertiary packaging component to a primary packaging component through various layers of cardboard and plastic packaging surrounding the primary product.”

According to the NWPCA, McNeil has not shared the results of its research. However, in a formal statement dated October 18th, 2010, the company said of its recall: “This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil for this lot were temporary and non-serious.”

The January issue of MHM broke the news of a massive recall of over-the-counter drugs made by McNeil Consumer Healthcare, which is one of J&J’s 250 subsidiaries. Subsequently, the FDA sent an official warning to Peter Luther, president of McNeil Consumer Healthcare’s North American over-the-counter business, saying it “did not conduct a timely, comprehensive investigation” of the complaints and committed “significant violations of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”