Wednesday, September 22, 2010

Panel asks if FDA knew about Secret J&J recall

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From Reuters:

The House Committee on Oversight and Government Reform on Tuesday said it had obtained an email in which an executive of J&J's McNeil consumer medicines unit described an agreement with the  FDA authorizing J&J to conduct an unpublicized recall of adult Motrin.

The committee said the agreement purportedly allowed McNeil to forgo a publicly announced formal recall of the Motrin product and to instead conduct a "soft market withdrawal." The committee for months has been examining what it describes as the "phantom recall" of Motrin, in which contractors quietly bought up stocks of the painkiller from store shelves.

The committee on Tuesday released a copy of a May 27, 2009, email from a McNeil executive to numerous colleagues, which cites a negotiated agreement with the FDA consenting to an unofficial recall of Motrin.
"This was a major win for us as it limits the press that will be seen," the email said, adding the company had promised the FDA to complete the informal recall by July 15.

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