FDA: J&J knew about problems year before recall

Posted May 27, 2010 at 12:32 p.m.

Associated Press | Johnson & Johnson learned of potency
problems with its Motrin formula in 2008, but instead of issuing a
recall, hired an outside contractor which began buying up the defective
products, according to congressional investigators.


Colleen Goggins, J&J’s president for McNeil consumer products, will testify before House lawmakers Thursday about ongoing quality problems with its over-the-counter medications.

Last month McNeil recalled more than 40 varieties of children’s medicines after Food and Drug Administration inspectors discovered a slew of violations at a company plant.

Some of the medicines recalled contained tiny particles of metal, though federal health regulators say the risk of health risks is remote.

The recall is the latest in a series that threaten to tarnish J&J brands like Tylenol and Benadryl.

Lawmakers will question Goggins about the latest problems as well as a 2009 recall.

According to FDA documents cited by congressional investigators, J&J learned of problems with some of its Motrin formulas in November 2008. The company hired an outside contractor to collect samples of the product and determine whether a recall was necessary.

But instead the contractor purchased shipments the defective product from retailers and instructed employees “not to mention a recall.”

J&J did not formally recall the products until July 2009, when FDA inspectors confronted the company about the contractor’s activities.

“This ‘phantom recall’ warrants further investigation by this committee,” said Rep. Edolphus Towns, D-N.Y., in his opening statement Thursday. “Who at McNeil and Johnson & Johnson knew about this scheme? How high up in the corporate suite was this scheme hatched?”

Towns chairs the House Committee on Oversight and Government Reform.

FDA deputy commissioner Joshua Sharfstein is scheduled to testify. Sharfstein is expected to provide new detail on problems uncovered at J&J’s Fort Washington, Pa., plant.

Since the April 30 recall, the FDA has received hundreds of reports of complications with J&J products, including seven deaths, according to a memo distributed to congressional staffers.

The FDA has not directly linked any medical problem to the recalled J&J products.

 

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