A spokeswoman for the US healthcare major said the recalled products were adult Tylenol eight-hour caplets being sold in 50 count bottles in the US and Puerto Rico, identifying them as part of Lot # BCM155.
The products in question, she continued, were manufactured in March at a factory in Pennsylvania, US which is operated by J&J’s McNeil Consumer Healthcare subsidiary.
The plant, in Fort Washington, was closed in May after the US Food and Drug Administration (FDA) pointed out lapses in quality control, including thick dust and grime, and contaminated ingredients; though the plant is due to reopen next year.
This latest recall is the third time J&J has pulled its OTC painkiller from the shelves from pharmacy shelves in the last two years after reports of musty odours.
In all three recalls the odour has been attributed to the presence of the compound 2,4,6-tribromoanisole (TBA) thought to have leached from wooden pallets used to ship and store product packaging materials.
2,4,6- tribromoanisole
The wood stain was also deemed responsible for musty odours associated with batches of J&J’s products Mortin and antacid Rolaids which, along with Tylenol, were part of a 53m bottle recall the firm undertook in January this year.
But J&J is not the only firm to have been impacted by 2,4,6- tribromoanisole contamination. In August, drug major, Pfizer recalled 191,000 bottles of its cholesterol fighting product, Lipitor, following three complaints of a “musty odour” emanating from the bottles.
This year US drugmaker, Depomed, also conducted a voluntary recall of 52 lots of its diabetes medication Glumetza 500mg tablets, due to a TBA contamination, thought to have originated from the pallets used to transport bottles to its contract manufacturer in Puerto Rico.