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.

ByABC News
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.

Watch 'ABC World News' tonight for more on this story.

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."