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| Documents prove J&J knew about unpublicised recall |
| Bloomberg / Washington Jun 13, 2010, 00:21 IST |
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Johnson & Johnson’s (J&J) McNeil consumer healthcare unit knew an unpublicised recall, in 2008, of faulty Motrin tablets would raise suspicion from US regulators, according to Food and Drug Administration (FDA) documents. The documents contradict statements made by Colleen Goggins, J&J’s consumer group chairman, at a May 27 hearing of the House Oversight and Government Reform Committee, in which she said the company hadn’t intended to mislead anyone about hiring contractors in the 2008 Motrin incident. The hearing was part of the committee’s investigation of J&J’s recall of infant and children’s Tylenol, Motrin, Zyrtec and Benadryl.
McNeil emails show the company was aware that its contractor, Inmar Inc, planned to buy the faulty Motrin to remove the over-the-counter painkiller from store shelves. The effort “may draw suspicion to what we are doing,” said an email from Inmar to McNeil. McNeil executives said the company was planning only to survey how much of the product had been sent to stores, according to Joshua Sharfstein, the agency’s principal deputy commissioner.
Widening investigation
The inquiry into the recalled children’s medicines has expanded to include McNeil’s handling two years ago of defective Motrin that weren’t dissolving properly. House lawmakers learned that consultants hired by McNeil tried to retrieve quantities of the 88,000 packages of faulty Motrin sent to gasoline service station stores without notifying FDA. Representative Edolphus Towns, the committee chairman, called the incident a “phantom recall.”
Emails obtained by FDA between McNeil and Winston- Salem, North Carolina-based Inmar include a memo urging the contractor to hide its identity when buying the faulty Motrin from the gas station stores. Inmar was among the contractors hired to visit 4,500 to 5,000 stores, according to the committee.
“These documents are extremely troubling,” Towns, a New York democrat, said today. “We can’t tell where the spin ends and the truth begins,” he added.
At the May hearing, Goggins said J&J didn’t know the contractors were buying the defective Motrin. “There was never any intent to mislead or hide anything from anyone,” she said. No phantom recall occurred and no safety risk existed for consumers from the defective Motrin, said Bonnie Jacobs, a spokeswoman for the New Brunswick, New Jersey-based company.
‘Fully informed’
“FDA was kept fully informed of McNeil’s plans and actions throughout the process,” Jacobs said. “The documents provided fully support the testimony previously provided to the committee. Given that there was no safety risk, the objective was to remove the affected product from a unique distribution channel, mainly convenience stores and gas stations, with as little disruption and consumer confusion as possible,” said Jacobs, who declined to provide the documents.
FDA disagreed with J&J on that point, said Meghan Scott, a spokeswoman for the agency. McNeil said it would “sample” from stores where the Motrin had been sent, she said.
“They did not inform the agency that they would instruct contractors to go into stores, ‘act like a regular customer,’ and buy all of the product in question,” Scott said in an email. After learning of the company’s actions, FDA pushed for an official recall of the Motrin, she said. FDA is looking into possible criminal penalties against J&J because of the recall of the children’s medicines.
J&J fell four cents to $58.46 at 4 pm in the New York Stock Exchange composite trading. The company has declined nine per cent since the children’s medicines recall.
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