FDA Pressures Johnson & Johnson for Broad Recall of OTC Drugs

Johnson & Johnson (J&J) has recently recalled certain lots of Tylenol, Rolaids, Benadryl and Motrin, after consulting with the U.S. Food and Drug Administration (FDA). McNeil Consumer Healthcare, the J&J subsidiary that sells the drugs, is voluntarily recalling the lots of the Over-The-Counter (OTC) products, in an effort to maintain the health and safety of the consumer and to prevent OTC medication errors.

The company has recalled these drugs based on consumer complaints of an unusual, moldy, musty smell that reportedly caused nausea, vomiting, diarrhea and gastrointestinal pain. The smell was found to be caused by trace amounts of the chemical 2, 4, 6-tribromoanisole (TBA)—a chemical often applied to wood pallets that are used in the transportation and storage of the materials used for product packaging.

The FDA has criticized J&J for not reacting quickly enough to customer complaints, and for failing to fix the problem, a problem that has been familiar to J&J. Customers have reportedly been complaining since 2008 about their pills having a mildew-like odor. In December of 2009, Tylenol Arthritis Pain medication was also recalled related this same issue.

According to the FDA, J&J and McNeil did not conduct a quick and comprehensive investigation into the problem, and failed to provide high quality products to consumers—responsibly protecting them from personal injury or illness. Many consumer complaints were received as early as 2008 and 2009, and the test results indicating TBA contamination were not shared with the FDA until after an inspection.

McNeill is continuing to investigate the issue and is reportedly taking further actions to discontinue the use of these wood pallets that contain TBA, to reduce the potential for consumer injury or illness from the products.

The recalled OTC drugs are Regular and Extra Strength Tylenol, Tylenol PM, Children’s Tylenol, Simply Sleep, St. Joseph’s Aspirin, Extra Strength Rolaids, Motrin IB, Benadryl and Junior Strength Motrin. These products are widely sold through a number of large chain drug stores and pharmacies, supermarkets and independent pharmacies.

CNN reported that the FDA has issued a serious warning letter to Johnson & Johnson, stating that the company has 15 days to address the problem and prevent future problems and violations—the failure of which could result in legal action, including seizure and injunction.

Lebowitz and Mzhen, LLC represent victims of medication mistakes in Maryland or the Washington, D.C. area. Contact our attorneys today for a free consultation.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji, PRNewswire, January 15, 2010
Tylenol Recall: What’s That Smell?, The Wall Street Journal, January 15, 2010
J&J Widens Recall Amid FDA Pressure, Forbes, January 15, 2010
Tylenol Recall: FDA Slams Company, CNN Money, January 15, 2010
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U.S. Food and Drug Administration: (FDA)

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