J&J lawyers: U.S. knew of Motrin ‘phantom recall’

By Reuters
Posted Sep. 22, 2010 at 1:57 p.m.

U.S. health regulators knew that Johnson & Johnson’s McNeil unit was using a contractor to buy back potentially faulty batches of Motrin, though there was no formal agreement with the government, lawyers for the company told lawmakers.

Still, in a letter to the House Oversight and Government Reform Committee Wednesday, J&J’s lawyers said though the purchases of defective painkiller¬† from retailers were legal, “moving forward the company would handle things differently.”

The letter came before a hearing next week into the diversified health care company’s recall of more than 40 products, including Children’s Tylenol, and the shutdown of one of its plants until at least next year.

The company has also come under fire for a “phantom recall,” in which J&J hired an outside company to purchase the faulty Motrin directly from retailers.

The Food and Drug Administration said that as soon as it learned of the problems, it called on McNeil to initiate a recall of the product.

But in their letter, obtained by Reuters Wednesday, the company’s lawyers said McNeil kept “FDA apprised of its actions” though there was no formal or written agreement over how to conduct the recall.

The company is “not aware of any indication” that the FDA disagreed with McNeil’s plan to hire a contractor to visit retailers, they added.

“We believe this record illustrates that McNeil acted with good intentions by keeping the FDA apprised of its actions and that there was no intent to conceal McNeil’s activities from the FDA,” the lawyers wrote in the Sept. 22 letter.

The House committee is scheduled to meet Sept. 30.

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One comment:

  1. JOHN C Sep. 22, 2010 at 9:28 pm

    terrible and sneaky behavior