Maker of children's drugs accused of hiding Motrin recall from public

When faced last year with Motrin IB caplets that were not dissolving properly, McNeil Consumer Healthcare, a division of Johnson and Johnson, hired contractors to buy the products under orders not to mention the term "recall," according to documents released by the House Committee on Oversight and Government Reform.

After the Food and Drug Administration discovered the effort -- because one of the contractors accidentally dropped an instruction sheet on the floor of a store -- McNeil announced a recall of roughly 88,000 packages of the product.

It became the first of four recalls of McNeil products in the past year, including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec, which have shaken consumers' confidence and threaten to stain Johnson and Johnson's brand name.

"It is a moral outrage for a company specifically marketing its products for children to allow a culture of neglect and irresponsibility to taint the medicines that parents and physicians trust to help children get well," said Rep. Darrell Issa (Calif.), the committee's ranking Republican, who displayed a bottle of Children's Tylenol at his seat.

The FDA, which is investigating McNeil's three production facilities in the United States and is considering criminal prosecutions, found multiple violations of good manufacturing practices at McNeil's largest facility in Fort Washington, Pa., according to FDA officials. The company stopped production at that facility in April just days before FDA officials conducted a two-week inspection that resulted in the recall of more than 40 varieties of the medicines for infants and children. It remains closed.

The recalled medicine may contain extra dosages of active ingredients and tiny particles that the FDA has identified as including nickel, chromium and cellulose. Some of the medicines also contained an ingredient that came from a master lot that was contaminated with a bacterium known as B. cepacia, according to the FDA.

The FDA has collected 775 reports of children and infants who experienced an adverse reaction after taking one of the recalled medicines, including 37 deaths.

But Joshua M. Sharfstein, a pediatrician and deputy FDA commissioner, said the illnesses and deaths appear to be side effects of the medicine and not related to its quality.

"Our experts believe the risk for any child in the U.S. was remote," said Sharfstein, a father of young children who said he had several of the affected medicines at home. "From what we know, we don't have evidence of children who had serious problems because of quality problems."

Colleen Goggins, a senior executive at Johnson and Johnson, told the committee that as a result of the problems, six senior executives were removed from their jobs, a consultant is helping redesign McNeil's manufacturing processes, and production at the Fort Washington plant will not restart until the company and the FDA are certain that improvements have been made.

"I apologize to mothers, fathers and caregivers for the concern and inconvenience caused by the recall," Goggins said. "We will work hard to earn back your confidence."

Sharfstein described how regulators grew increasingly concerned over the past year about McNeil's multiple recalls, its failure to adhere to its own quality standards, and its tardiness in fixing problems, responding to complaints and notifying federal regulators as required. "As manufacturing problems go, there were serious problems," he said.

It came to a head in February at an "extraordinary" meeting between FDA officials and senior executives at Johnson and Johnson, Sharfstein said. "We went over the heads at McNeil to talk to the corporate parent," he said.

Rep. Edolphus Towns (D-N.Y.), chairman of the committee, focused on what he called the "phantom recall" in which McNeil's contractors tried to quietly remove defective Motrin from stores in 2009. "I find this very disturbing," he said.

Goggins said the company had no intention of hiding a defective product. She said it hired a contractor to take a statistical sample of the amount of the affected Motrin IB in stores, so the company could decide whether to conduct a recall. But she could not answer further questions. "I can't tell you right now what they were instructed to do or not, sir," Goggins said.

Allan Coukell, a pharmacist and director of the Pew Prescription Project, which is aimed at improving drug safety, said after the hearing that he'd never heard of a "phantom recall."

"It's fairly shocking -- the idea that if there was a quality problem, they'd try to bring the product back instead of being transparent," he said.