A “phantom recall” of faulty Motrin tablets was pushed by the head of Johnson & Johnson’s McNeil Consumer Healthcare unit, according to emails obtained by a Congressional committee. The program, in which McNeil hired outside contractors to repurchase Motrin from stores, was not reported to consumers or federal regulators.
An investigation of the Motrin tablets, which didnâ€™t dissolve properly, is being conducted by the House Oversight and Government Reform Committee as part of an inquiry into <"https://www.yourlawyer.com/topics/overview/Childrens-Tylenol">childrenâ€™s Tylenol and other medicines recalled on April 30 by McNeil because of manufacturing defects. During a Committee hearing last month, it was learned that McNeil hired contractors to buy Motrin IB caplets under orders not to mention the term â€œrecallâ€ after learning in November 2008 that the drugs were not dissolving properly. A memo titled â€œMotrin Purchase Projectâ€ instructed the contractors to â€œon your schedule to locate and purchaseâ€ all of the Motrin eight-count packages. The document further instructed them to â€œâ€˜actâ€™ like a regular customer in making these.
McNeil finally recalled 88,000 packages of the drug in July 2009 after the federal regulators learned of the purchase effort. Since learning of the incident, Chairman of the House Oversight and Government Reform Committee, Edolphus Towns (D-NY), has referred to the Motrin purchase effort as a â€œphantom recall.â€
Bloomberg News obtained copies of emails from a source close to the investigation that show Peter Luther, president of McNeil since 2009, told employees to go ahead with what he termed a â€œmarket withdraw of Motrin.” â€œLetâ€™s make this happen ASAP,” he wrote.
A May 2009 email from Luther to six McNeil employees also showed that he had some concerns about the costs of the effort. â€œGiven our current financial situation, I hope weâ€™re not going to really double our cost to do this,” he wrote.
At the Oversight Committee’s May 27 hearing, Colleen Goggins, Johnson & Johnsonâ€™s consumer group chairman, insisted the company hadnâ€™t intended to mislead anyone about the Motrin incident. In a phone interview with Bloomberg, she continued to maintain that the Food & Drug Administration (FDA) was fully informed of the effort.
An FDA spokesperson told Bloomberg via email that McNeil only informed the FDA it would â€œsampleâ€ from stores where the Motrin had been sent, not that contractors would â€˜act like a regular customer,â€™ and buy all of the product in question.
But Bloomberg’s source said that Luther’s emails show that senior McNeil executives were involved with the plan to buy back the defective Motrin in large quantities, and that contractors weren’t merely performing a sampling to determine whether the product made it into stores.