Tylenol Recall

Musty odor sparks another Tylenol recall

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 United States. 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 U.S. 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 close 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 millions, 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 millions 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.

Asked if other J&J recalls may be in store, the company spokeswoman replied, "I can not speculate."

Tylenol Recall

A voluntary recall of Tylenol Arthritis Pain Caplets is being expanded because of consumer reports of an unusual moldy odor with the 100-count bottles, the U.S. Food and Drug Administration said late on Monday.

The FDA said it and Johnson & Johnson were expanding recall to all available product lots of the pain caplets with the distinctive red EZ-open cap.

The initial recall involved five lots of the product in November after reports of an unusual musty or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea, the FDA said.

The agency said the odor was believed to have been caused by the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.

It said the health effects of the compound have not been well studied, but the events reported to the company have been temporary and not serious.

The FDA said consumers who bought Tylenol Arthritis Pain Caplet 100-count bottles with the red cap from the lots included in the recall should stop using the product and contact McNeil Consumer Healthcare for a refund or replacement.