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 Unusual odor prompts wider drug recall

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PostSubject: Unusual odor prompts wider drug recall   Sat Jan 16, 2010 3:14 am

Johnson & Johnson's consumer division is recalling more than 53 million bottles of over-the-counter products including Tylenol, Motrin and Rolaids after reports of an unusual odor, expanding on an issue that led to a Tylenol recall last year.

The latest voluntary recall, which drew a sharp rebuke from U.S. regulators on Friday, followed consumer reports of "an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events," the company said. Such events included nausea, stomach pain, vomiting and diarrhea.

The Food and Drug Administration said the company had received about 70 complaints in 2008 of an intestinal problem or an unusual smell with Tylenol caplets but failed to report the problem to regulators until a year later.

The recall involves lots in the Americas, the United Arab Emirates (UAE), and Fiji. In addition to pain relievers Motrin and Tylenol, and the Rolaids antacid, the recall also involved the Benadryl allergy drug and St. Joseph's Aspirin.

A J&J spokesman said the financial impact from the two recalls would be recorded in its 2009 results, but it was not considered to be material. The company plans to comment further on the financial ramifications when it reports fourth-quarter results on January 26.

Shares of J&J fell 0.8 percent to close at $64.56 on the New York Stock Exchange, in line with a weak overall market. Separately on Friday, the U.S. Justice Department accused J&J of paying tens of millions of dollars in kickbacks to Omnicare Inc to buy and recommend J&J drugs.


FDA officials criticized the company's actions as slow and sent a warning to J&J's McNeil Consumer Healthcare unit.

"McNeil should have acted faster," Deborah Autor, head of compliance in the FDA's drugs division, told reporters on a conference call.

"When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary actions to solve the problem," she said.

The agency repeatedly urged McNeil to identify the source and scope of the problem, Autor said. The company ran more tests and expanded the recall at the FDA's urging, she said.

A McNeil spokeswoman said: "We'll be working with the FDA to respond to their letter."

According to McNeil, the unusual smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA), which can result from the breakdown of a chemical that is sometimes applied to wood for pallets that transport and store product packaging materials.

It was unclear how the chemical could have penetrated the bottles, a McNeil spokeswoman said.

"The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature," the company said in a statement.

The same chemical has been described in scientific literature as the likely cause of musty or "corked" odors in wines.

J&J, which also sells prescription drugs and medical devices, is one of the world's largest consumer healthcare companies, with scores of household staples such as Band-Aids and baby shampoo as well as the painkiller Tylenol.

McNeil Consumer Healthcare in December recalled about 5.2 million bottles of a form of Tylenol related to the chemical issue. The company said it has now applied broader criteria to identify and remove all product lots that may be affected, even if they have not been the subject of consumer complaints.

McNeil also said it was ceasing shipment of products produced using materials shipped on the wood pallets and requiring suppliers to stop using the pallets. It said it was continuing its investigation of the issue.

Democratic Representative Rosa DeLauro said the case demonstrated the need for the FDA to have mandatory recall power for food and drugs. "Millions of Americans have these unsafe products in their homes, and may have had them there for months," she said in a statement.

The FDA's letter to McNeil was posted at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm197811.htm
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