New Brunswick, NJThe FDA charges that in June 2009, Johnson & Johnson's McNeil Consumer Healthcare unit attempted to disguise its efforts to remove Motrin from store shelves without initiating a formal recall. The agency is looking into possible criminal penalties against J&J because of the Motrin recall.
The FDA said it became aware of the alleged Motrin cover-up after it obtained a memo, which was first sent anonymously to Oregon state regulators, detailing instructions to contract workers to buy up Motrin from stores.
According FDA documents obtained by Bloomberg, McNeil knew an unpublicized recall of faulty Motrin tablets would raise suspicion from U.S. regulators. Documents and e-mails show that McNeil's contractor, Inmar Inc., planned to buy the defective over-the-counter painkiller to remove it from store shelves.
The effort "may draw suspicion to what we are doing," said an e-mail from Inmar to McNeil. The contractors tried to retrieve large quantities of the 88,000 packages of faulty Motrin sent to gasoline service station stores without notifying the FDA. In a memo to Inmar, McNeil urged the contractor to hide its identity when buying the faulty Motrin from the stores.
At a May 27 hearing of the House Oversight and Government Reform Committee, McNeil executives said they didn't intend to mislead anyone regarding contractors in the 2008 Motrin Incident. Neither did they know that Inmar was buying Motrin. According to the committee, Inmar was hired to visit 4,500 to 5,000 stores. The New York Times reports that Representative Edolphus Towns (D-NY), chairman of the Committee, has accused Johnson & Johnson of using delaying tactics, and in some cases misinformation, to stymie his committee's investigation. The committee is "deeply concerned" about J&J's cooperation. Towns called the Motrin incident a "phantom recall."
Johnson & Johnson has been under scrutiny since April, when McNeil 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. At that time the FDA cited more than 20 manufacturing problems, including not properly testing for contamination of the recalled products.