Wood pallets cited as cause for McNeil’s Tylenol recall
What started out for McNeil Consumer Healthcare as a limited recall of Tylenol Arthritis Pain caplets, has swelled into a massive recall of products and caused a headache for the wood pallet industry.
The recall raises two questions: What was the source of the wooden pallets in question? And, are other U.S. manufacturers at similar risk if they are shipping on wooden pallets?
The short answers are that McNeil has not positively identified the source of the wooden pallets at issue. More importantly, 2,4,6-tribromoanisole, the chemical used to treat the wooden pallets in question, is not used to treat wooden pallets in the United States. Manufacturers and shippers using wooden pallets manufactured in the United States would not face a similar risk, according to industry experts.
Back in December, McNeil announced a voluntary recall of the Tylenol product due to consumer reports of an unusual musty, mildew-like odor that was being associated with unpleasant gastrointestinal symptoms. Since then, the recall has extended to other products, including additional Tylenol pain relievers, Motrin, Rolaids, Simply Sleep and St. Joseph products. All told, more than 54 million bottles of product have been recalled.
According to a statement by McNeil on Dec. 18, 2009: “The uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of the 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.”
The chemical, 2,4,6-tribromoanisole (TBA), can result from the breakdown of another chemical called 2,4,6-tribromophenol (TBP). McNeil contends that TBP from the wooden pallets degraded into TBA, which contaminated product containers and the finished product inside.
The wood pallets in question are believed to have originated in the Dominican Republic then used to ship product from McNeil’s manufacturing facility in Puerto Rico into the United States. However, it’s extremely difficult, if not impossible, to trace the exact origin of the wood, said Mark White, professor emeritus at Virginia Tech’s department of wood science.
White also explained that TBP is used in some parts of the world as a fungicide, but neither TBA nor TBP are legal to use domestically. “These chemicals are not registered for use in United States,” said White, “and that should give us some degree of comfort.”
That may be the only point offering comfort in this situation. McNeil’s slow response to consumer complaints has drawn the ire of the U.S. Food and Drug Administration (FDA), and pointing the finger at the wood pallets has the National Wooden Pallet and Container Association (NWPCA, http://www.nwpca.com) up in arms.
In their own defense, McNeil’s statement said, “The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.”
Regardless, in January, Deborah Autor, director of the FDA’s compliance office, publicly scolded McNeil. She said, “When something smells bad, literally and figuratively, you aggressively investigate and solve the problem.”