By Lyndsey Layton
Washington Post Staff Writer
Wednesday, May 5, 2010; A02
Federal officials said Tuesday that the sole plant that manufactures children's and infants' Tylenol, Motrin and other popular over-the-counter pediatric medicines lacked quality controls, used raw materials contaminated with bacteria and failed to investigate consumer complaints that some medicines contained black particles.
"The findings are serious," said Deborah M. Autor, a senior official at the Food and Drug Administration, which documented 20 problems at the Fort Washington, Pa., plant owned by McNeil Consumer Healthcare, a division of Johnson & Johnson. She said the agency is weighing whether to take action against McNeil, pending the completion of its investigation.
As FDA investigators were wrapping up a 10-day inspection of the plant last week, the company announced a voluntary recall of 43 over-the-counter pediatric medicines in the United States, its territories and nine other countries. The recall affects Tylenol, Motrin, Zyrtec and Benadryl, name brands widely used for pain, cold and allergy relief. Government sources estimate the recall could affect 70 percent of the market for pediatric over-the-counter medicines.
FDA officials said that McNeil received 46 consumer complaints between June 2009 and last month about "foreign materials, dark specks" in some medications but that the company failed to determine the cause and correct it.
Federal officials cautioned that the chances for serious harm from the recalled drugs are "remote," but FDA Commissioner Margaret A. Hamburg said parents and caregivers should immediately stop using the medicines. Generic versions are a safe alternative, Hamburg said. A list of recalled products and information about refunds is available on McNeil's Web site.
In documents released Tuesday by the FDA, investigators flagged the problems they observed at the McNeil plant, which they visited in part because of problems discovered late last year at a McNeil plant in Puerto Rico. In January, the FDA sent a warning letter to McNeil; in February, federal officials met with company executives.
"We had concerns about the company's failure to investigate and correct quality problems," Autor said.
At the Pennsylvania plant, the FDA identified defects in McNeil's quality-control methods and manufacturing processes, including a failure to track customer complaints and spot trends that may signal systemic problems, a lack of written procedures and a failure to adequately train employees.
Investigators found that raw materials had "known contamination" with unspecified bacteria and "were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products."
FDA officials said they could not identify the bacteria.
McNeil officials say the portion of raw materials in the medicines were tested and were not contaminated. "However, we understand the FDA's concern and will be working closely with them to address it," the company said in a statement. "The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us," the statement added.
The company has said that some of the recalled medicines may have a higher amount of active ingredient and that others may contain inactive ingredients that do not meet internal standards.