Tylenol Manufacturer Pleads Guilty to Selling Contaminated Medicine

Tylenol Manufacturer Pleads Guilty to Selling Contaminated Medicine

by / Monday, 16 March 2015 / Published in Defective Products

McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, has pleaded guilty to federal charges that they knowingly sold medicine that was contaminated with metal particles. The impacted medicine included over-the-counter liquid Tylenol and Motrin for children and infants. Fortunately, nobody was injured by the tainted medicine. The company will have to pay $25 million in fees to settle the case.

McNeil first became aware of the problem in May 2009 when they received a complaint about what appeared to be black specks in a bottle of Infant’s Tylenol. Some investigative steps were taken by McNeil and the specks were discovered to be particles of nickel and chromium and the problem was traced back to machinery at their plant in Fort Washington, PA. Although metal particles were found in the medicine, McNeil didn’t believe they posed a hazard to consumers and continued to manufacture the medicine for about a year afterward and did not immediately issue a recall. The Food and Drug Administration (FDA) found McNeil ignored a total of 46 consumer complaints about the black specks in children’s and infant’s Tylenol and Motrin.

In May 2010, McNeil finally launched a recall of the contaminated children’s and infant’s Tylenol and Motrin. It was just one of many recalls McNeil was involved in between 2008 and 2010. Since McNeil manufactures many different Johnson & Johnson products, there were recalls of types of Tylenol and Motrin in pill form, Zyrtec, Benadryl, Rolaids, Topamax, and more. Some of the problems that prompted the other recalls included improper labeling, some products potentially containing too much of an active ingredient, and products having a musty or moldy scent.

Investigations by the FDA found McNeil’s plant in Fort Washington to have poorly maintained machinery, materials contaminated with bacteria, and poor quality control practices. Job cuts may have also played a major role in the many recalls. In the years leading up to the recalls, the staff of the Fort Washington plant cut 478 jobs between 2005 and the end of 2009 and many of the jobs were filled by contract or temporary workers who were not properly trained. As a result of the FDA’s findings, they took over control over three McNeil plants: the Fort Washington plant, one in Lancaster, PA and another in Puerto Rico. The Fort Washington plant was closed in July 2010 for upgrades. Even though the plant has been completely rebuilt, it has not yet reopened. If it does reopen, they will be forced to improve their safety measures.

In addition to the $25 million in fines McNeil will now be paying for this case, all of the recalls during that time certainly had an impact on Johnson & Johnson’s bottom line. In 2010, sales of consumer Johnson & Johnson products dropped by 19% in the United States. Because of all the recalls, the company had two consecutive years of sales declines for the first time since World War II.

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