Smelly Tylenol Maker Responds to FDA Warning Letter

Johnson & Johnson has outlined the steps it has taken to prevent a repeat of the <"">musty-Tylenol debacle that occurred last year. Johnson & Johnson’s McNeil Consumer Health unit had been criticized by the Food & Drug Administration (FDA) for its handling of the incident.

The problems with musty Tylenol came to light in November, when McNeil recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP. The recall was issued after consumers complained of reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea.

That recall was expanded in December to include all lots of the Tylenol Arthritis Pain Caplets. Then in January, the list of recalled drugs was expanded yet again to include various lot of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the expanded recall included about 50 million bottles of the medications.

McNeil blamed the foul odor on contamination by a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials that leached into the products at a company plant in Las Piedras, Puerto Rico. The health effects of this compound have not been well studied, but McNeil has maintained that all of the reported adverse reactions have been temporary and non-serious.

In January, the FDA sent McNeil a warning letter over the whole mess, detailing manufacturing violations and quality problems. The letter charged that McNeil did not conduct a timely, comprehensive investigation, did not quickly identify the source of the problem, and did not notify authorities in a timely fashion, prolonging consumer exposure to the products. Deborah Autor, chief of compliance in FDA’s drug office, said at the time that McNeil knew about the problem in September 2008, but only let the agency know in September 2009.

Earlier this week, the FDA posted McNeil’s response to that warning letter on its Web site. In a letter dated February 5, McNeil said it is taking corrective and preventive actions to improve its quality assurance systems. Among other things, the company said it has changed the way it reviews consumer complaints so it can identify problems faster and take action more effectively, the letter said. The letter also said McNeil plans to conduct a comprehensive assessment of its quality management system, and was changing its investigation procedures.

An official for the FDA told The New York Times that it was in the process of reviewing the McNeil letter. “Our primary concern is protecting public health by determining what occurred and why it occurred, and ensuring that the company takes the needed corrective actions as stated in the agency’s warning letter,” said Richard Friedman, the director of manufacturing and product quality at the agency’s center for drug evaluation and research .

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