Bad Medicine

Jan. 1, 2010
Breakdowns in quality control and supply chain oversight caused a slew of drug recalls.

Big stories sometimes break when nobody’s paying attention. I saw it happen during the last week of December, when many of us were still sipping eggnog. McNeil Consumer Healthcare, the maker of Tylenol, announced a recall of all lots of Tylenol Arthritis Pain caplets in 100-count bottles. Consumers had complained to the Johnson & Johnson subsidiary about gastrointestinal ailments and “a moldy, musty or mildew-like odor.”

In one fell swoop, the blame went squarely on wood pallets. McNeil said the culprit is 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.” Alarmed pallet users, many from pharmaceutical and food companies, frantically called their pallet suppliers for assurance that wood pallets are safe.

But McNeil didn’t tell the whole story. TBA forms when a particular strain of fungus reacts with a fungicide called 2,4,6-tribromophenol (TBP), according to the Journal of Agricultural and Food Chemistry. At some point in the supply chain, TBP (or a related substance) came in contact with a fungus, converted into TBA and then contacted the Tylenol packaging. Since McNeil doesn’t identify the chemical it says was used to treat the pallets, all we can do is guess at where and how the contamination occurred.

It’s possible, though unclear, that McNeil is referring to methyl bromide, a wood packaging fumigation treatment approved under ISPM-15. But the National Wooden Pallet and Container Association (NWPCA) disputes that implication. An official memo to NWPCA members states: “TBA and TBP are not fumigants and not related to methyl bromide.” NWPCA also says that TBP is not legal for sale or use in the United States.

There’s more. After inspecting a McNeil manufacturing plant in Las Piedras, Puerto Rico, from October 2009 through Jan. 8, 2010, the FDA determined that McNeil failed to test the Tylenol in question for chemical contamination, despite receiving more than 200 complaints of a musty odor since 2008. McNeil told the FDA, according to the report, that wood pallets used to transport empty bottles from the bottle manufacturer to the product packager were to blame. But the drug manufacturer didn’t assess other products that received packaging components from the same supplier.

Even more shocking, the report notes that consumers also complained about a musty odor in Rolaids and Tylenol Extra Strength, but McNeil’s quality unit did not look for other sources of contamination in the facility or from external supply chain sources.

TBA might be new to McNeil, but the wine industry has known about it for years as “cork taint,” a moldy or musty smell that has cost winemakers billions in damages. A 2008 article in Practical Winery and Vineyard, a California-based industry journal, explains that TBP has been used as a fungicide in textiles, paint, plastics and paper and can also be found in epoxy resins, polyurethanes, antiseptics and certain detergents.

The article recommends that wineries demand certification from manufacturers of incoming goods that their products—including shipping materials—are free from TBP and related chemicals. It also tells winemakers not to use cleansers and sanitizers that can react with molds and to inspect and clean their facilities regularly.

Requiring inbound materials to meet quality criteria doesn’t seem revolutionary. Cleaning and inspecting facilities seems basic, too. McNeil should have revisited its internal quality-control processes and external supply chain policies instead of just passing the buck. Product was tainted under McNeil’s watch, so McNeil faces the recall, FDA investigation and negative publicity, not its suppliers. It’s the brand owner’s responsibility to control and monitor its supply chain to protect corporate image, the product itself and, in this case, consumer health.

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