Company behind recalls of kids’ drugs may face criminal penalties

Jun 1, 2010 by Andrew

The Johnson & Johnson unit that recalled millions of bottles of liquid children’s Tylenol and other pediatric medicines last month may face criminal penalties, product seizures or other sanctions, an official from the Food and Drug Administration said last Thursday.

The agency is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson unit, said Dr. Joshua M. Sharfstein, the FDA’s principal deputy comissioner, at a congressional hearing Thursday.

On April 30, McNeil voluntarily recalled more than 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec because they may have contained too much of the active ingredient of the drug, metal specks or inactive ingredients that failed testing requirements, the agency said. But McNeil’s problems go beyond those related to last month’s recall, including other forms of contamination, dating back two years.

Sharfstein noted lengthy delays by the company in reporting problems to the agency. And in one case, in 2008, he said, McNeil hired a contractor to quietly remove packages of Motrin from retailers for suspected quality problems — which he suggested was essentially an unannounced recall that was not reported to the FDA.

Sharfstein said the FDA was “considering additional enforcement actions against the company for its pattern of noncompliance. which may include seizures, injunction or criminal penalties.”

“I have become deeply concerned about your company,” Rep. Edolphus Towns, chairman of House Committee on Oversight and Government Reform, told the Johnson &. Johnson executive who testified. “It paints a picture of a company that is deceptive, dishonest and that has risked the health of many of our citizens.”

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