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After a series of Tylenol recalls, the matter has been referred to the Food and Drug Administration’s (“FDA”) crime division. Drug manufacturer McNeil Consumer Healthcare, a division of Johnson & Johnson (“J&J”), has recalled products from its lineup four times in the last seven months. These recalls included over forty kinds of liquid formulations of infant and children’s Tylenol, Motrin, Zyrtec, and Benadryl products on April 30th. According to Colleen Goggins, the worldwide chairman of Johnson & Johnson, production at McNeil’s Fort Washington, PA plant that manufactures children’s products has been suspended. Although Goggins testified that the recalls were not a result of adverse medical events, the FDA is investigating reports of at least 775 serious side effects from recalled drugs by McNeil.

Joshua Sharfstein, the FDA’s principal deputy commissioner, told lawmakers on the House Committee on Oversight and Government Reform that the agency was “considering enforcement actions against the company for its pattern of noncompliance, which may include seizure, injunction, or criminal penalties.” The FDA cited manufacturing problems that included bacterial contamination found in one of the raw ingredients used to make Tylenol. Another problem caused some of the medicines to contain higher concentrations of active ingredients than listed, while other products contained tiny metallic particles left as a residue from the manufacturing process. While Sharfstein said there is no evidence that contaminated raw material was actually used in the finished product and that the finished products tested negative for contamination, he believes the public health risk is too high for these manufacturing problems to have ever occurred.

Consumer complaints about moldy or musty smells from adult Tylenol products began in 2008. However, the product recalls did not begin until 2009. The FDA then sent McNeil a warning letter in January, criticizing the slow investigation process by the company. The investigation eventually found that the unusual odor came from trace amounts of a chemical applied to wood pallets for product storage. Unfortunately, the FDA only has so much influence over product recalls. The agency lacks the authority to initiate product recalls even when it discovers quality problems. In most situations, companies have the final say in whether to voluntarily issue a product recall, demonstrating again the importance of the judicial system and how we cannot rely solely on government agencies to monitor and ensure product safety.

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