Johnson & Johnson Recall Investigation ExpandedJun 2, 2010 | Parker Waichman LLP
Johnson & Johnson is facing an expanded Congressional investigation into ongoing quality issues with some of its over-the-counter medications. Yesterday, the chairman of the House Oversight and Government Reform Committee asked Johnson & Johnson for information regarding a possible “phantom” recall of Motrin tablets in 2008.
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 company also temporarily shut down production at the Fort Washington, PA facility that made the drugs. In April, the U.S. Food & Drug Administration (FDA) cited more than 20 manufacturing problems, including not properly testing for contamination of the recalled products. The problems prompted the FDA to widen its investigation of McNeil’s manufacturing practices, and it is now inspecting the company’s other facilities in Lancaster, PA and Puerto Rico. Officials from the agency have also said they were considering possible criminal charges against Johnson & Johnson and McNeil.
Last week, the House Oversight and Government Reform Committee conducted a hearing into the recall, which led to the revelation of the alleged phantom Motrin recall. 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 FDA was informed of the action.
McNeil finally recalled 88,000 packages of the drug in July 2009 after the FDA learned of the purchase effort.
In a letter dated May 28 and released yesterday, the Committee asked Johnson & Johnson 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.
“I have referred to this as a ‘phantom recall,’ but unfortunately it is all too real and extremely troubling,” committee Chairman Edolphus Towns, (D-NY) wrote to Johnson & Johnson Chief Executive Officer Bill Weldon.
“It raises the question of whether Johnson & Johnson placed a higher priority on preserving the reputation of its Motrin brand than it did on consumer protection,” Towns said.