The FDA criticized Tylenol manufacturer McNeil Healthcare LLC for a slow response to problems at a facility in Puerto Rico that led to consumers becoming ill by tainted pills.
McNeil voluntary recalled 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, which results from the breakdown of a chemical in wood pallets used to transport and store packaging materials for the drugs.
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. This 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.
Karen Hirshfield, acting branch chief of the FDA Office of Compliance’s Recalls and Shortages Branch said, “We would have expected McNeil to expand their investigation when they first learned of consumer complaints on this issue. They became aware of a problem in September 2008, and their investigation and report [to the FDA] didn’t occur until about a year later. We would have expected action to occur sooner than that.”
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 a toll-free number: (888) 222-6036.