The government may take criminal action against McNeil Consumer Healthcare, the Johnson & Johnson unit that that recalled millions of bottles of liquid children’s Tylenol, Motrin, and other over-the-country pediatric medicines last month.
Sloppy quality control and a lack of corporate responsibility led to the recall, Dr. Joshua M. Sharfstein, the F.D.A.’s principal deputy commissioner, said at a congressional hearing on the issue yesterday.
The FDA said the company may face criminal penalties, product seizures or other sanctions, according to The New York Times.
On April 30, McNeil voluntarily recalled more than 136 million bottles of liquid children’s 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. FDA investigators found bacteria in some raw materials.
“Although the public health risks from these quality problems is low, these problems should never have occurred. And the manufacturing failures at the facility that caused them were unacceptable,” said Dr. Sharfstein.
Johnson & Johnson has said that they are not aware of any serious illnesses that have resulted from use of the recalled products.
Thursday’s inquiry found that the company’s problems go back much further than last month. Apparently, the company was aware of problems with the drugs long before they issued the recall. In one case, after discovering some quality problems in Motrin, the company removed packages of the drug from retailers’ shelves without reporting it to the F.D.A.
Dr. Sharfstein also criticized the company for waiting a year to notify the FDA of odor problems with adult Tylenol pills manufactured at a Puerto Rico plant. The issue was later traced to a pesticide used on the wooden pallets which stored empty bottles, prompting a recall.
“I have become deeply concerned about your company,” Representative Edolphus Towns, the New York Democrat who is chairman of the 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.”
Colleen Goggins, who oversees J&J’s consumer business, acknowledged that the quality issues which led to the recall were “unacceptable,” but assured the committee that the company informed the FDA of its actions and didn’t have “any intent to deceive or hide anything.”
Earlier this week, an F.D.A. spokeswoman said that the agency had received reports of health issues associated with the recalled products, including several deaths. But the agency has not found evidence that the products caused the reported health problems.
McNeil vows to overhaul its manufacturing and quality control processes, including executive changes, employee training and new procedures for investigating potential problems with products.
Meanwhile, the FDA assures consumers that any medicines currently on store shelves are safe to use.