FDA scolds Johnson & Johnson for slow action on Tylenol recall

By Bloomberg News
Saturday, January 16, 2010

The Food and Drug Administration sent a warning letter to Johnson & Johnson, saying the drugmaker waited more than a year to notify regulators after getting complaints that tainted bottles of Tylenol sickened customers.

The company's McNeil Consumer Healthcare Division had received complaints of an unusual odor in bottles of Tylenol Arthritis Pain caplets early in 2008 and knew it might have had a more widespread problem by September of that year, said Karen Hirshfield, acting chief of the FDA's Recalls and Shortages Branch, in a conference call with reporters Friday. The company did not notify the agency until last September and expanded a recall on Friday only at the FDA's urging, she said.

"They became aware of the problem in September 2008, and their investigation and report to the agency didn't occur until about a year later, and we would have expected action to occur sooner than that," Hirshfield said.

The FDA's warning letter alleged violations of manufacturing, notification and quality-control rules. The company is working with the FDA to respond to the warning letter and will not comment further, Marc Boston, a McNeil spokesman, said in a telephone interview.

McNeil pulled 500 lots of Rolaids; Motrin; Children's Tylenol; regular, extra-strength and eight-hour Tylenol; Benadryl; St. Joseph's Aspirin; and Simply Sleep caplets in the Americas, the United Arab Emirates and Fiji.

The medicines may have been tainted by a pesticide and flame retardant applied to wooden shipping pallets, the company said in a statement. Johnson & Johnson received about 70 complaints of musty or mildew-like odors in Tylenol caplets as well as reports of nausea, vomiting and diarrhea after use, the FDA said.

The FDA said both recalls came after regulators pushed the company to expand the scope of its investigation at the Las Piedras, Puerto Rico, plant where the Tylenol was made. The agency has no authority to order recalls, Hirshfield said.

"The initial investigation by McNeil was very limited, in our view," she said. "We would have liked them to extend their investigation into areas that were very limited."

The agency is also "concerned about the response of Johnson & Johnson," the warning letter said. Even after the FDA registered complaints about the company's review, "Neither upper management at J&J nor at McNeil Consumer Healthcare assured timely investigation and resolution of the issues."

Johnson & Johnson has 15 days to respond to the warning letter, said Deborah Autor, compliance director in the agency's Center for Drug Evaluation and Research. The company could face legal action and approval delays if it fails to promptly respond.

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