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FDA Expands Investigation into Tylenol Recall

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New York, NYThe Food and Drug Administration (FDA) is expanding its investigation into the circumstances surrounding Johnson & Johnson's (J&J) recent recall of children's non-prescription medicines, following the release of a damning inspection report of the facility that manufactured the recalled drugs.

According to a report on, the 17-page document chronicled 20 violations uncovered at the Fort Washington, PA plant owned by J&J subsidiary McNeil Consumer Healthcare. David Lebo, professor of pharmaceutical manufacturing at Temple University, told CNN in an earlier interview that the report is "absolutely shocking" and "pretty close to being the worst I've seen. It suggests that basically the FDA found an issue with almost every system at the plant." One of the most frightening findings listed in the report is that the plant didn't appear to maintain adequate facilities on-site for testing and approval or rejection of the components used in the medicines it manufactured. Following the recall, J&J closed the Fort Washington plant.

The report also noted that McNeil had not followed up on 46 consumer complaints it had received between June 2009 and April 2010, complaints that mentioned the presence of foreign materials and black or dark specks in the medicines.

The May 1 recall included 50 children's versions of non-prescription drugs, including Tylenol, Motrin and Benadryl.



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