FDA offers new details about kids' Tylenol, Motrin recall

An inspection report by the U.S. Food and Drug Administration has revealed disturbing details about the McNeil Consumer Healthcare manufacturing plant that produced liquid versions of infant and children's products, including Tylenol, Motrin, Zyrtec and Benadryl, that were recalled last week.

The Fort Washington, Pa., plant apparently wasn't checking its products for bacteria, properly testing its batches, safety storing materials and labels and was in general disarray, inspectors found. Overall, they found quality control virtually non-existent.

The new details came as the FDA again urged consumers to halt using the products and to shift to alternatives. Generic versions of the over-the-counter products are not affected by this recall and are considered safe.

"I want to take this opportunity to underscore some important messages for consumers and in particular parents," FDA Commissioner Dr. Margaret Hamburg said. "Please discontinue using any of the name brand products being recalled. While the potential for serious health problems is remote, Americans deserve medications that meet FDA standards for quality, safety and efficacy. There are many alternative versions for many of these medications available in generic forms."

A just-released preliminary inspection report said that McNeil failed to properly oversee manufacturing procedures. Among problems cited was that McNeil failed to properly check for "gram negative" organisms -- which an FDA official described as bacteria.

The report said: "It does not maintain adequate laboratory facilities for the testing and approval (or rejection) of components and drug products. It neglects review and approval of validation protocols regarding changes in product processes and equipment to determine when revalidation is or should be warranted, It is in default in investigations, tracking, trending and maintenance of consumer complaint follow-up; and it lacks trending of products, components (i.e., water), and complaints to demonstrate a broad perspective to assure plant conformance with [good manufacturing processes]."

FDA officials at a news conference said they had no evidence that anything produced at the plant was in fact contaminated but also no way to know otherwise, since normal procedures to check during manufacturing weren't followed.

They also said that the April inspection capped concerns that already had caused FDA officials to meet in February with officials of McNeil and parent Johnson & Johnson.

"The initial assessment is that the findings are serious," said Deborah M. Autor, director of the FDA's office of compliance at the Center for Drug Evaluation and Research.

She said the investigator saw "numerous deficiencies" and described the findings as "serious" but said the agency is still evaluating whether to seek additional action against the company.

"It is yet another example of the need for companies to take full accountability for the quality of their drugs and the serious consequences that can happen when companies do not do so," she said.

McNeil said in a statement responding to the FDA report and press conference that it would provide a detailed response to the FDA on its observations and will work to see they are addressed.

"We have no higher concern than providing parents with the highest quality products for their children," the statement said. "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, and not indicative of how McNeil Consumer Healthcare intends to operate.

"While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused."
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