Documents show J&J bought Motrin before recall

Johnson & Johnson planned to remove potentially flawed lots of its Motrin over-the-counter pain reliever from store shelves by having contractors buy stocks of it, documents obtained by Reuters show.

One memo under the logo of McNeil Consumer Healthcare, a unit of J&J, instructed a contractor identified as Inmar: “Do not communicate to store personnel any information about this product. Simply visit each store, locate the product and, if any is found, purchase all of the product.”

The Motrin recall came to light during a congressional hearing concerning J&J’s widespread April recall of its Tylenol, Motrin, Benadryl and Zyrtec products for infants and children.

As part of its investigation into the April recall, the U.S. House Committee on Oversight and Government Reform began probing a recall of some adult versions of pain reliever Motrin. The documents obtained by Reuters refer to this recall taking place in 2009.

During a May 27 hearing, Committee chairman U.S. Rep. Edolphus Towns cited a document it had received from the Food and Drug Administration and said it showed that “rather than issue a public recall, McNeil allegedly sent contractors out to stores to buy the product back and told the stores ‘not to mention’ a recall.

“After the FDA confronted McNeil about this, McNeil announced a recall of the affected products. This ‘phantom recall’ warrants further investigation by this Committee,” Towns said.

On Friday, Committee spokeswoman Jenny Rosenberg said, “The Committee is deeply concerned about Johnson & Johnson’s response and cooperation with our investigation.”

In response to Reuters questions about the documents, J&J spokeswoman Bonnie Jacobs said: “The FDA was kept fully informed of McNeil’s plans and actions throughout the process.” McNeil agreed to a recall as soon as the agency requested it, she said.

In the internal McNeil document, dated April 1, 2009, instructing “Inmar Field Analysts” to buy Motrin from store shelves, provided a product code and other information specific to the product in question. The memo said: “It is not necessary to check for any other product. Only the product code and lots indicated above.”

That memo was attached to an email exchange between Inmar and J&J employees, in which one Inmar employee responded to a request to purchase two lots of Motrin:

“This adds a new dynamic that we need to discuss. If the product is in dispensers we will have to remove all the products and physically review them. This will take time and may draw suspicion to what we are doing.”

Another document, an email from the FDA to J&J, focused on the word “retrieval.”

“It seems that your company is doing a recall even though you are calling it a ‘retrieval,’” FDA investigator Neisa Alonso wrote in the July 16, 2009 email.

J&J REFUTES CLAIMS

On Friday, J&J disputed allegations that the company had executed a “phantom recall.” J&J spokeswoman Jacobs said that because there was no safety risk, the company had sought to “remove the affected product from a unique channel - mainly convenience stores and gas stations - with as little disruption and consumer confusion as possible.”

The product was recalled because “McNeil’s internal tests showed that some tablets might not dissolve as quickly as intended,” she said, adding: “There was no patient health or safety risk, nor any consumer complaints.”

Jacobs said that wholesalers had been told that the product would be removed from store shelves.

“The FDA was kept informed of the survey and product retrieval and after it was essentially complete the FDA requested that we conduct an additional step, which was to conduct a formal recall, and we agreed,” Jacobs said.

A New York Times report on Friday quoted Committee Chairman Towns, a New York Democrat, as saying the committee was “not getting the kind of information and cooperation from Johnson that I would like.” He was cited as saying that J&J had used delaying tactics in its dealings with the committee and in some instances had provided misinformation.

That might compel the committee to take more aggressive action as it looks into drug quality and safety issues raised by the recall, Towns was quoted as saying.

Committee spokeswoman Rosenberg confirmed that Towns’ remarks in the report were accurate.

The report cited Jacobs as saying the company had been very cooperative with the committee and confirmed it had provided about 20,000 pages of documents, made its executives available for interviews and answered queries in a timely manner.
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By Lewis Krauskopf

NEW YORK (Reuters)