May 5th, 2010
From The Philadelphia Inquirer:
McNeil Consumer Healthcare has voluntarily shut down the Fort Washington plant where it produces Children’s Tylenol and dozens of other recalled over-the-counter medications in response to an FDA report that said raw ingredients contaminated with bacteria had been used in some of the infants’ and children’s products.
The Food and Drug Administration said it had so far found no evidence of bacteria in any finished products it tested. At a news conference Tuesday afternoon, agency officials said they considered harm to children unlikely from the microorganisms or from previously identified problems with the McNeil medications, including inconsistencies in product potency and other contaminants.
“We think at this point that the risk to consumers is remote,” said Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. However, Autor said the inspection found “numerous deficiencies in the ways in which McNeil products were manufactured.”
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