Food and Drug Administration inspectors found in April that McNeil Consumer Healthcare, which has voluntarily recalled certain lots of its children's and infants' Tylenol products, knowingly used bacteria-contaminated materials to make them, a report posted Tuesday by the agency says.
FDA officials said no batches of the final product have been found to be contaminated, but the agency must further review inspectors' observations "in order to have a definitive conclusion," Douglas Stearn, assistant director of the agency's compliance office, said at a news conference.
McNeil, which on Friday announced the recall of 1,500 lots of children's and infants' Tylenol, Motrin, Zyrtec and Benadryl, has suspended production at the plant in Fort Washington, Pa., where they were manufactured.
"We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there," the company said in a statement Tuesday. The statement didn't specifically address the problems cited in the FDA inspection report but did say that "we will provide a detailed response to the FDA on their observations and work diligently to ensure that they are addressed."
Though the known risk to consumers "is remote," the FDA's Deborah Autor said, "we have theoretical concerns" about the safety of the recalled products.
"The report posted today cites numerous deficiencies in the way McNeil products were manufactured," said Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. "The FDA's initial assessment is that the findings are serious, but we cannot yet say whether further action is warranted." Such actions range from warning letters to fines, she said.
Stephen Byrn, founder of Purdue University's pharmacy quality compliance program, said that though he doesn't doubt that the risk of health problems from the recalled lots is remote, the type and scope of manufacturing problems cited by FDA inspectors make it difficult to have confidence in the plant's products.
FDA representatives met with McNeil officials in February to express "serious concerns" about whether the company was following good manufacturing practices in its plants, Autor said.
The meeting followed McNeil's voluntary recall in January of certain lots of Tylenol Arthritis Pain medication made in its plant in San Juan, Puerto Rico. The company said consumers had complained about an odd odor from some of the recalled lots that, in a small number of cases, was linked to digestive tract upsets.
The Fort Washington plant also makes adult-strength pill versions of the recalled drugs, Autor said. But, she added, there was no evidence any of those products should be recalled.
Contributing: Alison Young
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