For the third time this year, a common medication has been recalled for a musty or mildew-like smell emanating from bottles. On Tuesday, Johnson & Johnson issued yet another voluntary recall — of adult Tylenol 8-Hour caplets (50-count bottle) — due to trace contamination of 2,4,6-tribromoanisole (TBA), a component of a chemical preservative contained in wooden pallets that are used to ship and store packing boxes.
The timing is inconvenient for the company, which is currently the subject of a congressional investigation for repeated quality control lapses detected by Food and Drug Administration (FDA) inspectors at J&J’s McNeil Consumer Healthcare facility in Fort Washington, Pa. The plant is now closed. Reuters reported:
The FDA cited thick dust, grime and contaminated ingredients at the Fort Washington plant. J&J plans to reopen the plant next year, and is using other McNeil plants to help offset lost production of the recalled products.
Products made at the plant had annual sales of about $650 million, about 1 percent of total annual company sales. But the spate of recalls has tarnished the reputation of J&J and its consumer brands and forced a shakeup at the McNeil unit.
On Oct. 19, J&J recalled 128,000 bottles of adult Tylenol 8-Hour caplets linked to the shuttered plant. In January, the company pulled 53 million bottles of adult and children’s Tylenol, Motrin, St. Joseph’s aspirin and Rolaids — also produced from the Pa. plant — from store shelves. (Before that, in Dec. 2009, J&J recalled bottles of Tylenol Arthritis Pain for the same funky odor.) And on Oct. 8, in an unrelated incident, Pfizer recalled 191,000 bottles of Lipitor because of the same type of TBA contamination. (More on Time.com: Top 10 Product Recalls)
Turns out, pill bottles are not the only victims of TBA. A recent study in the Journal of Agriculture and Food Chemistry found that the compound was responsible for the musty, “corked” taste of many spoiled wines. (That’s one of the possible spoilages you’re testing for when a server pours a taste in your glass before you commit to a bottle of wine.)
Despite its unpalatable smell and taste and possibly unsanitary origins, there are no known adverse health effects that result from TBA. However, the J&J drugs recalled in Dec. 2009 and January of this year were accompanied by consumer reports of nausea, vomiting, diarrhea and abdominal pain. Regarding the Oct. 19 recall, the company said: “To date, observed events reported to McNeil for this lot were temporary and non-serious.”
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