For immediate release: Wednesday, June 2, 2010
Contact: Jenny Rosenberg, (202) 870-4923

Chairman Towns Questions Circumstances Surrounding Recall of PediaCare

Children’s medication manufactured at Johnson & Johnson/McNeil PA facility

WASHINGTON – Chairman Edolphus “Ed” Towns (D-NY) has serious questions about the conditions of a Johnson & Johnson/McNeil plant that is now connected to the recall of four types of PediaCare, a popular children’s medication.  The committee is already investigating the recall of popular over-the-counter pediatric medications and a form of Motrin that were manufactured at the same Fort Washington, PA plant and subsequently recalled.

On Friday, May 28, 2010, Blacksmith Brands announced the PediaCare recall.  The committee is asking Blacksmith Brands Chairman and Chief Executive Officer Peter Mann to provide details about the PediaCare recall including what led to the recall which the company calls “precautionary.”

“We cannot take any recalls at this plant lightly,” said Chairman Towns.  “Nothing is more important than the health and welfare of our children and as I have said before, we will continue to ask tough questions about these incidents."

The plant where the PediaCare, Motrin and more than 130 million bottles of pediatric medicine are produced was shut down prior to the May 2010 recall of the 130 million bottles.

A copy of the letter to Blacksmith Brands is included below.

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June 2, 2010

Mr. Peter Mann
Chairman and Chief Executive Officer
Blacksmith Brands
200 White Plains Road
Tarrytown, New York 10591

Dear Mr. Mann:

The Committee on Oversight and Government Reform is the principal oversight committee in the U.S. House of Representatives, with jurisdiction over “any matter.”  Under Rules X and XI of the Rules of the House of Representatives, the Committee is investigating the recent recall of over-the-counter Johnson & Johnson/McNeil pediatric products.

On May 28, 2010, Blacksmith Brands announced a recall of four PediaCare children's medicines that were manufactured at the same Johnson & Johnson/McNeil plant that was shut down in connection with Johnson & Johnson’s recall of over 130 million bottles of pediatric medicine.

To assist the Committee in its investigation, please provide the following information and records:

1. Is Blacksmith aware of any defect or contamination in any Blacksmith product that was manufactured at Johnson & Johnson/McNeil's Fort Washington, Pennsylvania plant?  If so, please explain.
2. Has Blacksmith received any reports of adverse events related to the recalled Blacksmith products?  If so, please provide a list of all such adverse events.
3. Please provide copies of all records relating to Blacksmith’s May 28, 2010 recall of pediatric medicine, including all communications between Blacksmith and Johnson & Johnson, McNeil, and the U.S. Food and Drug Administration.

Please deliver the requested information and records to the Committee on Oversight and Government Reform, room 2157 Rayburn House Office Building, no later than 4:00 p.m. on Thursday, June 10, 2010.  To facilitate delivery and review, we prefer that the records be delivered in digital form.  Please note that the terms “records” and “relating to” are defined in the attachment to this letter.

Sincerely,

Edolphus Towns
Chairman