Behind the 'phantom recall' of Motrin

New York (News Today) - A congressional committee is widening its investigation of a drug making arm of Johnson & Johnson to include an attempted 2009 "phantom" recall of Motrin.

The House Committee on Oversight and Government Reform was already looking into several recalls by the division, McNeil PPC, and charges by the Food and Drug Administration of sloppy drug-making processes.

Now it is looking into FDA charges that in June 2009, McNeil attempted to disguise its efforts to remove Motrin from store shelves without initiating a formal recall.

After the FDA learned of the effort, it prompted McNeil to initiate a nationwide recall of more than 88,000 tablets of Motrin because of a problem with the way the drug dissolved, according to an FDA enforcement report.

The FDA said it became aware of the alleged Motrin scheme after it obtained a memo that detailed instructions to contract workers to buy up Motrin from stores. The memo was first sent anonymously to Oregon state regulators.

"You should simply 'act' like a regular customer while making these purchases. There must be no mention of this being a recall of the product!" reads the memo dated June 12, 2009.

The FDA could not identify the other companies involved, named in the memo as WIS and CSCS.

The FDA said it was aware that McNeil was using a contractor to remove a sample batch of the product, but not at such a wide scale.

"Once we learned of the contractor's activities, the FDA asked McNeil to initiate a recall, and the company complied," the agency said in a statement.

The FDA subsequently classified the Motrin recall as Class 2, meaning the recalled products have a low chance of causing major injuries or death, but still pose some risk of "adverse events."

It appears that McNeil never issued a press release about the recall. Companies are not required to issue press releases for Class 2 recalls, though most companies do, as did McNeil for four other Class 2 recalls in the past year.

The FDA, which typically posts such press releases, confirmed that it does not have a press release from McNeil about the Motrin recall.

McNeil would not comment on whether it publicly disclosed the recall. The House committee has given Johnson & Johnson until 4 p.m. on June 7 to provide more information and records. McNeil said it is looking into the memo and "will respond back to the [congressional] committee."

FDA spokeswoman Elaine Gansz Bobo said the agency could not yet determine if McNeil violated any regulations with its actions.
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"This product appears to have been adulterated because it didn't meet dissolution specifications," said David Rosen, who worked at the FDA for 14 years and now advises major pharmaceutical companies on FDA regulation and compliance. However, Rosen said the law prohibits a company to introduce or deliver a product that is adulterated or misbranded into the marketplace.

McNeil Consumer Healthcare, a division of Johnson & Johnson, has initiated four recalls of its over-the-counter drug products such as Tylenol, Motrin, Zyrtec in the past eight months.

The drugmaker last month shut production at its Fort Washington, Pa., plant where its recalled children's drugs were manufactured and pledged to remedy serious quality and safety lapses at its manufacturing facilities.

Source : CNN

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