A Tylenol recall issued last year by the Johnson & Johnson unit of McNeil Consumer Healthcare because of chemical contamination has been expanded for a second time to include Benadryl Allergy Ultratablets and Extra Strength Tylenol.
The latest recall includes four lots of Benadryl Allergy Ultratab tablets in 100 count bottles sold in the U.S. with lot numbers AJA008, ADA194, ABA022 and ABA264, and one lot of Tylenol Extra Strength Rapid Release Gel Cap with lot number ASA202.
Click HERE to see a complete list of recalled medications
The initial Tylenol recall expansion that was issued Jan. 15 included Rolaids, Tylenol Extra Strength, and a number of other medicines. The company's press release stated that the latest expansion was issued because the medications were mistakenly left out of the original recall.
McNeil recalled the medications after consumer complaints of a "musty or moldy odor," the press released stated. A company investigation concluded that the smell came from a breakdown of a chemical that is applied to the wood used to build the boxes that transport and store packaging materials.
The U.S. Food and Drug Administration previously slammed Tylenol manufacturer McNeil Healthcare LLC for what it called a slow response to problems at a facility in Puerto Rico that led to consumers becoming sickened by tainted pills.
"McNeil should have acted faster," said Deborah Autor, director of the FDA's Office of Compliance, of the arm of Johnson & Johnson that manufactures Tylenol products. "When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem."
A recall of Tylenol products began in December 2009 with the popular Tylenol arthritis caplet expanded to include more than two dozen other over-the-counter products manufactured by McNeil.
The previous recall totaled 60 million bottles, according to the company. It is unclear how many are included with the latest announcement.
McNeil initiated a voluntary recall of Tylenol Arthritis Relief Caplets at the end of December after consumer complaints of stomach problems. The problems were linked to the presence of a chemical called 2,4,6-tribromoanisole (TBA), which results from the breakdown of a chemical in wood pallets used to transport and store packaging materials for the drugs.
The problem extended to other Tylenol products as well, according to the FDA.
The FDA declined to comment to senior health and medical editor Dr. Richard Besser about the latest recall, saying the case has been referred to the criminal division for investigation.
In January, McNeil said that the musty-smelling chemical thought to be the cause of the sickness posed no fatal risk to those who ingest it.
"The health effects of this chemical have not been well studied, but no serious events have been documented in the medical literature," the January statement read.
"In addition to the product recall, McNeil Consumer Healthcare is continuing its investigation into the issue and is taking further actions that include 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."