NEW YORK (CNNMoney.com) -- As Johnson & Johnson was quietly removing defective Motrin from store shelves, it ignored regulators who said the problems with the drug warranted an official recall, according to documents obtained by CNNMoney.com.
"It seems that your company is doing a recall even though you are calling it a 'retrieval.' The agency's position is that your company should do a voluntary recall of the product since it appears that you already are doing a recall of the product," Neisa Alonso an FDA investigator in San Juan, Puerto Rico wrote in an email to a J&J (JNJ, Fortune 500) executive dated July 16, 2009.
Alonso explained further that the problems with Motrin, which Johnson & Johnson brought to the FDA's attention in late 2008, typically result in a product recall.
The FDA does not have authority to force companies to issue recalls, but the agency does issue guidelines to help firms decide when to conduct a recall.
If there is a reasonable probability that the product will cause serious adverse health effects or death, the company should issue a Class 1 recall.
Class 2 recalls should be made if a product defect could cause temporary or medically reversible adverse health consequences, but have a remote probability of serious adverse health consequences. Class 3 recalls should be issued if a product defect is not likely to cause serious health consequences.
A company can do a "market withdrawl," which is not a recall, when there's a minor problem with the product that's not tied to the company's manufacturing or distribution practices.
The agency subsequently classified the Motrin recall as Class 2.
On Monday, the Committee on Oversight and Government Reform, which is investigating J&J's drug recalls, disclosed documents that suggested the FDA may have known and approved McNeil "secret" Motrin recall.
In an email dated May 27, 2009 and CC'd to McNeil president Peter Luther, a McNeil executive wrote:
"We have negotiated agreement with FDA not to formally conduct a recall for Motrin 8's but rather conduct a 'soft market withdrawal.' This is a major win for us as it limits the press that will be seen. We had committed to FDA to complete this withdrawal by July 15th."
The FDA maintains that after the agency learned of McNeil's effort, it prompted McNeil to initiate a nationwide recall of the Motrin tablets. However, consumers never found out about the recall because McNeil/J&J never issued a press release about the recall.
On Tuesday the FDA issued a statement again maintaining that the agency was not aware of and had not signed off on McNeil's "phantom recall" of Motrin.
"Any effort to suggest to the contrary is based on quoting documents selectively and out of context and ignores other evidence as to what occurred," the statement said.
"When the FDA learned that McNeil had hired contractors to secretly purchase product off the shelves, the agency advised McNeil to do a full recall which the company agreed to initiate in July 2009. FDA then voiced its objections about McNeil's 'phantom recall' activities to the senior leadership of Johnson & Johnson in a February 2010 meeting," the FDA said.
J&J executives told lawmakers during a Congressional hearing about the recalls in May that the company did not try to hide its Motrin recall plans from the FDA.
Late Tuesday, the committee requested that J&J "deliver a copy of an alleged agreement between McNeil and the FDA that permitted McNeil to forego a formal recall of the Motrin product and instead conduct a 'soft market withdrawal.'"
J&J CEO William Weldon, was given until Wednesday to provide the proof.
In April, McNeil recalled 135 million bottles of children's and infant's Motrin, Tylenol, Benadryl and Zyrtec drugs for quality issues. It was the largest recall of children's non-prescription drugs.
Lawmakers and regulators initiated investigations into the recalls, including a criminal investigation, after documents released in June revealed that McNeil also tried to conduct a "phantom" recall of more than 88,000 Motrin tablets in June 2009.
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