McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, recalled another lot of Tylenol due to the continued presence of musty or moldy odor first noted in medications manufactured by the company in a 2009 recall.
The lot in question, number ADM074, involves Tylenol 8 Hour Extended Release Caplets sold in a 150-count bottle. “The risk of adverse medical events is remote,” the company wrote on it’s website, noting that the musty odor is thought to be caused by trace amounts of certain chemicals — 2,4,6-tribromoanisole and 2,4,6 trichloroanisole.
The product was manufactured at the McNeil Consumer Healthcare plant in Fort Washington, PA, which voluntarily closed its doors in April 2010 as part of an FDA investigation into questionable quality control and manufacturing procedures at the facility.
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Since 2009, McNeil has recalled products including Benadryl, Motrin and Rolaid, most often because of musty odor, but also because of complaints that products contained bits of metal and wood.
Earlier this March, McNeil agreed to a consent decree with the FDA and the U.S. Department of Justice, halting all manufacturing and distribution at three of its plants until each is certified compliant with good manufacturing practice regulations. The facilities in question include the Fort Washington plant, another in Lancaster, Pa., and a third in Las Piedras, Puerto Rico, according to an earlier press release.
In addition to the Tylenol 8-Hour Extended Release Caplets, McNeil expanded a wholesale-level recall initiated on January 14, 2011 to include 10 additional OTC medications. A list of the products in question can be found, here.
The company encourages clinicians and consumers to report any adverse reactions associated with the products to the FDA’s MedWatch Adverse Event Reporting program.
