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]."