The company's recall started last September and was limited to certain lots of Tylenol, although that recall was expanded in December. The recall now includes certain lots of Motrin, Benadryl, Rolaids and St. Joseph aspirin.
To date, there have been some 70 reports from consumers about the problem, and in some cases using these products has resulted in nausea, stomach pain, vomiting and diarrhea, Autor said.
The company believes the contamination was caused by a chemical used to treat the wooden pallets on which packaging material is transported and stored. The chemical, 2,4,6-tribromoanisole (TBA) also occurs naturally and has been blamed for giving wine a moldy taste.
"The health effects of this chemical have not been well-studied, but no serious events have been documented in the medical literature," Autor said. According to McNeil, it is possible that the TBA leeched into the packaging material and then into the products themselves.
While Autor commended the company for broadening its recall to include products that consumers have not complained about, she chastised them for acting too slowly to report and investigate the problem.
The first complaints of a musty odor in Tylenol Arthritis Relief Easy Cap products reached company officials in May 2008, but it wasn't until September of that year that the company began to investigate the problem.
Then, McNeil did not notify the FDA of the problem until September 2009, Autor said. "When something smells bad -- literally or figuratively -- companies must aggressively investigate and take all necessary action to solve the problem," she stressed.
Since then, the agency has repeatedly urged McNeil to identify the source of the problem and to recall affected products. Under current law, the FDA cannot order a recall, Autor noted.
The first recall of products was in early September 2009; the recall was expanded in December 2009 to include all Tylenol Arthritis Relief caplets. In addition, the FDA inspected McNeil's primary manufacturing plant in Las Piedras, Puerto Rico.
Based on this data, the agency has sent McNeil a warning letter citing multiple violations of "good manufacturing practice requirements," Autor said. "[The] FDA also warned McNeil for failing to report quality problems to the agency."
"McNeil and all drug manufacturers have a corporate responsibility to ensure their products are high-quality, safe and effective," Autor said. "When a problem arises with their products they must be proactive, quick and thorough in order to assure the quality, safety and effectiveness of their products and protect consumers."
For its part, McNeil said this in a statement released Friday: "In addition to the product recall, McNeil Consumer Healthcare is continuing their investigation into this 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. We will continue to closely monitor and evaluate the situation and consult with the FDA."
Recalled products include specific lots of:
- Regular Strength Tylenol
- Extra Strength Tylenol
- Children's Tylenol
- Tylenol 8-Hour
- Tylenol Arthritis
- Tylenol PM
- Tylenol Simply Sleep
- Children's Motrin
- Motrin IB
- St. Joseph aspirin
SOURCE: Jan. 15, 2010, teleconference with Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration