In the Tylenol Blame Game, Accountability Proves Tough to Swallow
In the January issue of MHM, we broke the news of a massive recall of over-the-counter drugs made by McNeil Consumer Healthcare, one of Johnson & Johnson’s 250 subsidiaries.
It started with Tylenol Arthritis caplets but has since expanded to include Motrin, Rolaids and many other types of Tylenol-branded medications. The full list of recalled drugs is 14 pages long.
After our January issue hit the street, the FDA turned up the heat by sending an official warning to Peter Luther, president of McNeil Consumer Healthcare’s North American over-the-counter business. In the letter, the FDA blasts McNeil, 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.”
Nevertheless, McNeil stands behind its original statement that the odor comes from a chemical used to treat the wood pallets that transported its product. The company also assures consumers that it is taking further actions, including “ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets.”
Good idea, McNeil, but you’re a little late.
The FDA claims McNeil received consumer complaints of a moldy or musty odor coming from its products back in 2008, but the drug company shrugged them off as isolated incidents. And, the FDA inspected the company’s manufacturing plant in Puerto Rico and found serious quality-control problems.
In his blog, Marc Monseau, director of corporate communications and social media at Johnson & Johnson, says McNeil conducted a microbiological investigation back in 2008 and found no bacteria or mold, leading the company to conclude that the complaints were just flukes. In 2009, Monseau writes, the company got more complaints, so it decided to investigate further. That’s when the 2,4,6-tribromoanisole (TBA) was found.
I don’t know about you, but Monseau’s words do nothing to settle my stomach. Why didn’t McNeil conduct a comprehensive investigation when it first received complaints in 2008? The company should have looked for chemical contamination—not just bacteria and mold—in the first place.
Now, the company has opened a Pandora’s box of chaos and conflict in the material handling community.
This week, plastic pallet supplier iGPS fired off a statement warning of the “dangers of wood pallets.” Tests commissioned by iGPS revealed the presence of bacteria and “life-threatening pathogens” in wood pallets, according to the release.
CHEP, a provider of wood and plastic pallet pooling services, posted a special memo on its Web site assuring customers that its pallets are safe. Jim Ritchie, president of CHEP USA and Kevin Shuba, president of CHEP Americas, highlighted the company’s strict quality-control procedures and its use of kiln drying (not chemical preservatives or fumigation) to control infestation and mold growth.
Meanwhile, the National Wooden Pallet and Container Association (NWPCA) is fighting mad. In a recent letter to Johnson & Johnson CEO William Welson, Bruce Scholnick, NWPCA’s president, stated that McNeil’s “highly irresponsible and defamatory statements” have inflicted “immense damage” on the wood pallet industry and its business relationships.
Scholnick 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.” If Johnson & Johnson fails to deliver this evidence, NWPCA says it will demand a retraction and then pursue damages.
To ease concerns of wood pallet users and suppliers, the NWPCA posted a fact sheet about the recalls on its Web site.
NWPCA also fired away at the plastic pallet industry by posting this video showing a Maine legislator introducing a bill to ban deca-bromine (reportedly used in plastic pallets):
In my humble opinion, the blame for all of this falls on the brand owner, and that’s McNeil and ultimately Johnson & Johnson. As the FDA put it in its warning letter, “Corporate management has the responsibility to ensure the quality, safety and integrity of its products.”
I realize that nobody’s perfect. But if you’re distributing products that will be swallowed by millions of men, women and children in 57 countries, you’d better be darn close. Accountability is a tough pill to swallow, but with great power comes great responsibility.







