The U.S. Food and Drug Administration slammed Tylenol manufacturer McNeil Healthcare LLC during a media briefing Friday morning 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, adding "When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem."
A recall of Tylenol products has began last month with the popular Tylenol arthritis caplet expanded to include more than two dozen other over-the-counter products manufactured by McNeil.
The broadened directive adds 54 million bottles of product to the recall, boosting the total number of bottles recalled by McNeil to approximately 60 million, according to the company.
McNeilinitiated 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.
Now it appears that the problem extended into other Tylenol products as well, according to the FDA.
Tylenol Extra Strength, Rolaids and a number of children's medicines are now included in the recall, which affects 27 products in various packaging quantities.
McNeil released a statement today in which it said the voluntary recall is being conducted in consultation with the FDA and affects a number of products for which there have been no complaints.
The company added 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 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."
In its statement, the company advised consumers who purchased the affected products to stop using them and contact McNeil for information about how to get a refund or a replacement. The company provided the address for its Web site, www.mcneilproductrecall.com, as well as a toll-free number: (888) 222-6036.
Prior to today's recall, the FDA had cited at least two of the company's products in a letter to McNeil, as these products had been the subject of complaints about an "uncharacteristic smell," similar to the one that helped trigger the recall of the arthritis caplets.
"Since the date of the discovery, your firm did not extend the assessment of the event to other products that received packaging components from the same supplier," said the FDA's letter, which was signed by Jose R. Lopez, an investigator, and Raquel Gonzalez Rivera, a chemist.
The letter goes on to cite over 10 "musty-moldy odor" complaints about Rolaids and over 39 similar complaints about Tylenol Extra Strength, "including three adverse event reports."