J&J recalls more products after unusual odor

NEW YORK/WASHINGTON (Reuters) - 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 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 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."