Tylenol recalls 60,912 bottles due to "musty" odor reports

Reuters News
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Posted: Jun 29, 2011 5:43 PM
Tylenol recalls 60,912 bottles due to "musty" odor reports

By Molly O'Toole

WASHINGTON (Reuters) - A Johnson & Johnson subsidiary is recalling 60,000 bottles of extra strength Tylenol following consumer complaints and the detection of a "musty, moldy" odor, a spokesman said on Wednesday.

"It was in response to complaints and McNeil's detection," Marc Boston, a McNeil Consumer Healthcare spokesperson, told Reuters Wednesday.

The consumer healthcare company is a division of McNEIL-PPC, Inc., in turn a subsidiary of Johnson & Johnson.

"This was discovered as part of our ongoing surveillance monitoring protocol for musty, moldy complaints," Boston said in an emailed statement adding to his earlier comments.

McNeil Consumer Healthcare on Tuesday announced the voluntary recall of one product lot, or 60,912 bottles, of "Extra Strength" Tylenol caplets, following reports of an "uncharacteristic" odor.

Boston said no further information is being released at this time.

The moldy odor has been linked to traces of a chemical called tribromoanisole (TBA). TBA has been associated with an "offensive odor" and temporary gastrointestinal symptoms, according to a news release from McNeil.

"This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote," the release stated.

The callback is the latest in a string of U.S. recalls of Tylenol and other nonprescription drugs for Johnson & Johnson in the past year.

In March 2011 Johnson & Johnson reported that following repeated recalls it would make its U.S. over-the-counter business a separate organization.

That same month U.S. health authorities said they would closely supervise three Johnson & Johnson manufacturing plants where quality-control lapses have led to recalls of more than 300 million bottles and packages of over-the-counter medicines.

One manufacturing plant had been closed almost a year for quality purposes.

The Tylenol being recalled this week was manufactured in February 2009.

The McNeil statement said customers should stop taking the identified Tylenol products and contact the company. The product lot number for the recalled product can be found on the side of the bottle label.

McNeil is conducting the recall with the knowledge of the U.S. Food and Drug Administration.

(Editing by Jerry Norton)