Chairman Towns Asks J&J for Proof of FDA Involvement in "Phantom Recall" of Motrin

WASHINGTON – As part of the committee’s ongoing investigation into Johnson & Johnson’s “phantom recall” of an adult Motrin product, Chairman Edolphus “Ed” Towns (D-NY) is requesting that Johnson & Johnson provide a copy of an alleged agreement between McNeil Consumer Healthcare and the Food and Drug Administration (FDA) that permitted McNeil to forego a formal recall of the Motrin product and instead conduct a “soft market withdrawal.”  The alleged agreement with the FDA is cited by a McNeil executive in an email to other McNeil executives – a document provided to the committee by Johnson & Johnson.

Chairman Towns is asking for a copy of the agreement to clarify the issue of whether or not the FDA permitted McNeil/Johnson & Johnson to conduct a phantom recall of the affected Motrin rather than engage in a formal recall.  Chairman Towns asked Johnson & Johnson’s CEO to provide the requested document by 12:00 noon, Wednesday, September 22, 2010.

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 Documents and Links

Letter to Johnson & Johnson requesting agreement with FDA for "phantom recall."

May 27, 2009 Email from McNeil Executive citing agreement with the FDA.