A chemical used to treat wood pallets has been identified as a possible source of the contamination of various pharmaceutical products, which are being recalled by the manufacturer. Prompted by the U.S. Food and Drug Administration (FDA), pharmaceutical company McNeil Consumer Healthcare, a division of Johnson & Johnson, has recalled various caplet, tablet and chewable products such as Benadryl, Motrin, Rolaids, St. Joseph Aspirin and Tylenol.
The problem was first discovered on Tylenol Arthritis caplets. In November 2009, McNeil recalled five lots of the medication due to consumer reports of a moldy, musty or mildew- like odor that in some cases led to nausea, stomach pain, vomiting and diarrhea. McNeil says the stomach problems reported by consumers were temporary and not of a serious nature.
According to a statement issued by McNeil, the odor is caused by a chemical called 2,4,6-tribromoanisole (TBA), the source of which is believed to be “the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.” The chemical McNeil refers to may be the fungicide 2,4,6-tribromophenol (TBP), which can be converted into TBA by strains of a fungus. TBA has been identified as one of the chemical compounds responsible for “cork taint,” a moldy or musty smell that contaminates wine. For years, the wine and cork industries have grappled with controlling 2,4,6-trichloroanisole (TCA), a compound related to TBA and most often associated with cork taint, which reportedly has cost the wine industry about $10 billion in damages worldwide.
Chemicals other than fungicides, as well as a wide range of wooden materials (including, but not limited to, wood packaging material), have been implicated in the formation of TCA and TBA. According to Professional Friends of Wine, a wine-connoisseur group, molds capable of converting chemicals into TCA or TBA may be present in raw materials or in wooden walls, stairs, pallets and boxes.
Bob Moore, chairman and CEO of iGPS, a maker of plastic pallets, believes the McNeil recall is evidence that “wooden pallet shipping platforms are a dangerous threat to the pharmaceuticals we depend on.” The time has come, he suggests, that the FDA begin regulating wood pallets.
However, in an interview with MHM, Bruce Scholnick, president of the National Wooden Pallet and Container Association (NWPCA), a trade group for the wood pallet industry, points out that U.S. wood pallet manufacturers and recyclers “do not use TBP, which is banned in this country, nor do they use it in Europe. However,” he notes, “it is used in South America.” The pills were never contaminated, he explains, as it was the plastic in the bottles that carried the odor, not the caplets.
In an e-mail alert to its members, NWPCA states that it is unfortunate that certain plastic pallet providers “are working to provoke fears that are largely ungrounded.” The plastic pallet industry itself has come under fire from regulators over its use of chemical fire retardants.
Meanwhile, the FDA has released a report indicating that McNeil’s awareness of the odor problems dates back to 2008, that the company received more than 200 complaints about musty odors and that other products manufactured at McNeil’s Puerto Rico facility also received similar complaints. For instance, Tylenol Extra Strength received 39 complaints about musty odors, and Rolaids received 10 such complaints. The FDA suggests that McNeil was lax, both in responding to the complaints and in subsequent testing of the products and the pallets to identify the cause of the odors.
For material handlers, one of the lessons learned, according to Adrian Gonzalez, director of logistics viewpoints with analyst firm ARC Advisory Group, is that “there’s been a lot of focus on packaging in recent years, particularly in using less of it from a ‘green’ perspective. But in addition to the quantity of packaging used, companies should also consider the composition of the packaging materials used.”