NEW YORK – A moldy odor has again stricken Johnson & Johnson's Tylenol, and the company is recalling another lot of the over-the-counter painkiller.
J&J, which has recalled tens of millions of bottles of Tylenol and other consumer medicines in the past year because of complaints of a musty or moldy odor in the product, said it was voluntarily recalling another lot.
The company, which is facing a U.S. congressional probe of quality control lapses that have led to its numerous recent recalls of Tylenol, painkiller Motrin and allergy treatment Benadryl, said almost 128,000 bottles of Tylenol have been recalled in the latest action.
"This voluntary action is being taken as a precaution and the risk of adverse medical events is remote," the diversified healthcare company said in a release.
A company spokeswoman identified the product as adult Tylenol eight-hour caplets sold in 50-count bottles in the United States and Puerto Rico.
She said the recalled lot was made in March at a factory in Fort Washington, Pennsylvania, operated by J&J's McNeil Consumer Healthcare unit.
J&J shut down the McNeil plant the following month and is upgrading the facility to correct quality control lapses discovered by U.S. Food and Drug Administration inspectors.
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.
One of J&J's largest recalls in the past year, on January 15, involved 53 million bottles of Tylenol, Motrin and antacid Rolaids because of musty or moldy odors. The smell was traced to a chemical called 2,4,6-tribromoanisole present in wooden pallets that transport and store product packaging materials.
J&J on Tuesday reports third quarter earnings, which are expected to be hurt by the massive recalls of its iconic consumer healthcare brands.
Asked if other J&J recalls may be in store, the company spokeswoman replied, "I can't speculate."