Children's Tylenol Recall: Did 'Culture of Mediocrity' at McNeil Labs Affect Children's Medicines?

Gov't could take criminal action against Johnson & Johnson for recalled drugs.

May 27, 2010, 4:27 PM

May 27, 2010— -- The government said today it may take criminal action against the giant pharmaceutical company Johnson & Johnson over sloppy quality control that led to last month's massive recall of over-the-counter infant's and children's liquid medicines.

For a list of all of the products recalled, click here.

The recall of products made by J&J's McNeil Consumer Healthcare subsidiary took 136 million bottles of medicines off the shelves, including 40 varieties of popular brands such as Children's Tylenol, Infant's Tylenol, Children's Motrin, Children's Zyrtec and Children's Benadryl. The recall involved 70 percent of the market for those products.

Both the Food and Drug Administration and J&J say there is no evidence yet that any child has been harmed from using one of the recalled products, but the investigation continues. The FDA says brands currently being sold in drugstores are safe to use.

Nevertheless, the FDA said if parents are concerned, they should buy generic medicine for their kids.

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The products were recalled April 30, 2010, after the FDA found problems with their quality, purity and potency. Manufacturing deficiencies were found at McNeil's plant in Fort Washington, Pennsylvania, which has since closed and remains shut down. It was the third major recall of McNeill products in eight months due to quality problems, including some drugs whose foul odor reportedly made customers vomit.

Joshua Sharfstein, principal deputy commissioner at the FDA, told the House Committee on Oversight and Government Reform, the agency was "considering additional enforcement actions against the company which may include seizure, injunction and criminal penalties."

Deborah Autor, the head of FDA's Office of Compliance, said, "The FDA's center for drugs has referred this to FDA's criminal investigative unit, and then they have to judge where to go from there." FDA officials said they did not know how long such a review would take.

Sharfstein said, "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."

Johnson & Johnson Calls Problems 'Unacceptable'

The head of Johnson & Johnson's Consumer Group, Colleen Goggins, agreed. "The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable," she said."On behalf of McNeil and Johnson & Johnson, I apologize to the mothers, fathers, and caregivers for the concern and inconvenience caused by the recall."

But Goggins defended the company's handling of the recall and denied it ever knowingly used any contaminated products. She said McNeil has "made significant organizational changes," hiring new officials to oversee quality and plant operations.

Committee chairman Rep. Edolphus Towns, D-New York, said, "There is nothing this committee will investigate that is more serious than the health of our children. We will use all of our authority to find out what went wrong and do everything that we can to ensure that it does not happen again."

Rep. Towns wanted an assurance no one could give him. "Can you say with complete certainty that no children who took the medicines that were recalled last month were harmed by them?" he asked.

"No, I cannot say that with complete certainty," Sharfstein replied. But he added that no injuries or deaths have been attributed to any of the recalled medicines.

One member of the committee said McNeil was guilty of a "culture of mediocrity." Another called it a "sloppy shop."

FDA inspectors in late April cited McNeil's Fort Washington, Pennsylvania, plant for a variety of lapses that included bacterial contamination of ingredients, filthy equipment and the potential for medicines to be too potent.

One incident occurred as long ago as November 2008, when McNeil uncovered problems with an adult version of Motrin. Chairman Towns produced documents alleging McNeil told the FDA it wanted to sample the affected Motrin already at retailers. But outside contractors it hired instead bought up the products in question and were told to act like customers and not to mention a recall, according to lawmakers and the FDA. After the agency found out, McNeil recalled the product.

Goggins denied the company tried to avoid a recall by buying up the product and said the FDA was aware of McNeil's actions. Nonetheless, Rep. Towns found "unanswered questions here that are very troubling."

Goggins acknowledged, "The entire episode is extremely embarrassing."

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