J&J pulls more Tylenol over labeling problem

By Dow Jones Newswires-Wall Street Journal
Posted Nov. 24, 2010 at 11:45 a.m.

Johnson & Johnson, which has been recalling a number of popular over-the-counter medicines, said Wednesday it’s withdrawing more Tylenol because of a labeling problem.

The company’s McNeil Consumer Healthcare unit is recalling nearly 9.3 million bottles of three Tylenol Cold Multi-Symptom products from drug stores and suppliers because the bottles’ front labels didn’t show they contain small amounts of alcohol from ingredients that flavor the medicine.

The bottles’ boxes and back labels did reflect the presence of alcohol. The company said the alcohol amounted to less than 1 percent of the medicine’s contents.

The labeling problem doesn’t threaten the health of consumers, who don’t need to return or stop using the medicines, according to the company. “Consumers don’t need to take action and can continue to take the product,” said a company spokeswoman.

Yet it highlights the continuing fallout from the manufacturing problems that have bedeviled J&J.

The company has indicated more such actions are likely, as it tries to bring its manufacturing up to compliance under the watchful eye of regulators.

That scrutiny follows a string of more serious manufacturing problems at the company that have led to more than a half-dozen withdrawals of Tylenol and other over-the-counter medicines, some contact lenses and certain hip-replacement parts. Due to those issues, some over-the-counter medicines could have been more potent than they should have been, contained metal shavings or had a musty smell causing nausea.

The recalls are costing the company hundreds of millions of dollars in lost sales and prompted the temporary shut-down of a key manufacturing plant and a revamping of manufacturing. The company has also shuffled management.

Only in recent weeks has some grape-flavored children’s Tylenol started returning to shelves, after a half-year of being out of stores.

In the wake of the problems, the company has been conducting a review of its operations. That review led to a recall of some Benadryl and Motrin last week and of the Tylenol Wednesday. Because the recalls aren’t considered to pose a safety issue, the company has posted the news on its Websites, but hasn’t otherwise given public notice.

The company is likely to conduct more recalls, as it goes over the results from its review.

The latest recalled products were made for J&J’s McNeil unit by a contract manufacturer, whom the spokeswoman wouldn’t name.

The 8-ounce Tylenol multi-symptom bottles recalled are daytime citrus burst, nighttime cool burst and severe day cool burst.

For more information, consumers can go to www.tylenol.com or call 1-888-222-6036.

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