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U.S. lawmakers seek data from FDA on J&J recall

By Lewis Krauskopf

NEW YORK (Reuters) - U.S. lawmakers on Thursday requested information from regulators about Johnson & Johnson's recall of Children's Tylenol and other over-the-counter pediatric medicines, saying the company's repeated recalls "point to a major problem" with production.

The U.S. House of Representatives Committee on Oversight and Government Reform has opened an investigation after J&J recalled 40 widely used children's pain and allergy medications, saying some may have a higher concentration of their active ingredients, while others may be contaminated.

In a damning FDA report issued on Tuesday, inspectors said they found thick dust, grime and contaminated ingredients at the J&J plant that produces Children's Tylenol and dozens of other products recalled last week.

J&J has now had four recalls in the past year of over-the-counter medicines.

"Taken together, these recalls point to a major problem in the production of McNeil products," Committee Chairman Edolphus Towns, a New York Democrat, and the panel's ranking Republican, Darrell Issa of California, said in a release, referring to J&J's consumer healthcare unit.

"Given McNeil's questionable track record and consecutive recalls, we need to understand what prior actions the (Food and Drug Administration) took to address McNeil's quality control problems and what events led the FDA to its April 2010 inspection of McNeil's Fort Washington plant."

The committee requested information and records in a letter to FDA Commissioner Margaret Hamburg, which was included in its press release on Thursday.

The committee is seeking to clarify the timing of the events that spurred the recall in order to understand J&J's and FDA's response, according to the release.

Among other questions, the letter asks Hamburg to identify the bacteria found in raw materials at McNeil's Fort Washington, Pennsylvania, plant, where the pediatric products in question were made.

The FDA will promptly review the committee's letter and information request, a spokesman said.

"We will certainly respond to those inquiries and fully cooperate with the committee's investigation," the agency spokesman said.

J&J's McNeil unit declined to comment.

In a release on Wednesday, the lawmakers said they were questioning the adequacy of the FDA's inspection procedures and whether J&J's McNeil unit failed to investigate consumer complaints that could have identified the contamination problems.

The committee said it expects to hold a hearing "in the coming weeks."

J&J shares were down 1.4 percent at $63.72 in afternoon trading on the New York Stock Exchange.

(Reporting by Lewis Krauskopf; Editing by Steve Orlofsky)

(Reporting by Lewis Krauskopf; editing by John Wallace)

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