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New Tylenol Recall Due to Musty Odor

Johnson and Johnson Recalls About 60,000 Bottles of Tylenol Extra Strength Caplets

By Bill Hendrick
WebMD Health News

Reviewed By Laura J. Martin, MD

June 29, 2011 -- Johnson & Johnson has announced a recall of 60,912 bottles of Tylenol Extra Strength Caplets because of reports that some containers had an "offensive" odor that has been associated with gastrointestinal symptoms.

The announcement was made by McNeil Consumer Healthcare, one of J&J's companies. McNeil says in a news release that the product was manufactured in February 2009, and that it was recalling the pills following a "small number" of reports of a musty, moldy odor.

Chemical Causes Unpleasant Odor

McNeil said the odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA), which is a by-product of a chemical preservative sometimes used on shipping pallets.

The company said it was taking the action as a precaution and that the risk of serious adverse medical events is "remote."

McNeil Consumer Healthcare said consumers who bought the product from the lot being recalled should stop using it and contact the company on its web site or by calling 888-222-6036.

Each recalled bottle contains 225 caplets. The company said the lot number on the product is ABA619 and the UPC code 300450444271.

Gastrointestinal Problems

In addition to causing unusual, unpleasant odors, TBA has been associated with temporary and non-serious gastrointestinal symptoms.

In March 2011, the McNeil division of Johnson & Johnson recalled one lot, or 34,056 bottles, of Tylenol 8-Hour Extended Release caplets due to a musty odor.

In April 2011, the company issued a voluntary recall of 57,000 bottles of its epilepsy drug Topamax due to complaints of a foul odor associated with the tablets.

SOURCES:

News release, McNeil Consumer Healthcare.

McNeil Product Recall web site.

© 2011 WebMD, LLC. All rights reserved.



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