Lawmaker Looking into “Phantom” Motrin Recall

Johnson & Johnson, already under fire for a massive recall of children’s medicine issued in April by its McNeil Consumer Healthcare Unit, is now facing another investigation. This one involves an alleged “phantom recall” of some Motrin tablets that occurred in 2008.

Last week, the House Oversight and Government Reform Committee conducted a hearing into the children’s medicine recall, which led to the revelation of Motrin incident. Documents released by the Committee showed that McNeil hired contractors to buy Motrin IB caplets under orders not to mention the term “recall” after learning in November 2008 that the drugs were not dissolving properly. A memo titled “Motrin Purchase Project” instructed the contractors to “on your schedule to locate and purchase” all of the Motrin eight-count packages. The document further instructed them to “‘act’ like a regular customer in making these purchases.”

Neither the public nor the U.S. Food & Drug Administration (FDA) was informed of the action. Once the FDA inadvertently learned of the Motrin project, McNeil recalled 88,000 packages of the drug in July 2009.

Now the House Committee wants to know more about that incident. In a letter dated May 28 and released yesterday, the Committee chair Edolphus Towns, D-NY, asked Johnson & Johnson to provide a “detailed description” about the hiring of outside contractors or employees used to remove products from stores. It also requests all records relating to the 2008 Motrin incident, as well as the names of the contractors used in the Motrin purchase effort.

Johnson & Johnson has been under scrutiny since April, when its McNeil Consumer Healthcare unit recalled more than 40 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid.

The recall was the largest involving children’s medicines in the history of the FDA, and involved 70 percent of the market for over-the-counter pediatric liquid medicines.

A memo prepared by Congressional staffers that was released last week revealed that between January 2008 and April 2010, the FDA received 775 reports of adverse events – including 30 deaths – involving the recalled drugs. After the recall, the agency received several hundred more complaints, including seven deaths, the memo said.

The FDA is still investigating some of the adverse event reports to determine if the events were related to a child taking one of the recalled medicines.

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