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34,000 Bottles of Tylenol 8 Hour Extended Release Recalled

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Washington, DCJohnson & Johnson has announced yet another recall - this time it involves 34,000 bottles of Tylenol 8 Hour Extended Release Caplets. This brings the total of products recalled by J&J and its subsidiary McNeil Consumer Healthcare, to 300 million medication and medical products over the past 15 months, reports.

The caplets were recalled because of consumer complaints about a musty odor, which J&J indicated may be due to a chemical that is sprayed on the wooden pallets that hold the bottles of Tylenol during storage and shipping. The same musty odor has prompted five other recalls by the company.

The lot number of the recalled pain medication is ADM074. The product was manufactured in a plant in Fort Washington, Pennsylvania.

On January 14, 2011, in consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, recalled at the wholesale level, certain lots of TYLENOL 8 Hour, TYLENOL Arthritis Pain, and TYLENOL upper respiratory products, and certain lots of BENADRYL, SUDAFED PE, and SINUTAB products distributed in the United States, the Caribbean, and Brazil. These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended.

On March 14, 2011, the FDA filed a consent decree of permanent injunction against and two of McNeil-PPC’s officers for failing to comply with current good manufacturing practice requirements as required by federal law. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.



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