Off Topic -Tylenol, Motrin Recall

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J & J recalls more products after unusual odo

Boxes of cold medication are seen in a pharmacy in Toronto Reuters – Boxes of

Tylenol cold medication are seen in a pharmacy in Toronto January 31, 2008.

REUTERS/Mark Blinch

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By Krauskopf and Richwine Krauskopf And Richwine – 2 hrs

30 mins ago

NEW YORK/WASHINGTON (Reuters) – & '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. ph'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 CRITICIZES J & J

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 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

(Reporting by Krauskopf, Richwine, Ransdell Pierson; Editing by

Caney, , Tim Dobbyn)