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Laura Woods | March 16th, 2015

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J&J subsidiary pleads guilty in Tylenol case

On March 10, McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, pled guilty to selling medicine contaminated with metal. The company agreed to pay $25 million to settle the case.

In 2010, the drug maker recalled many children’s over-the-counter medicines, including Children’s Motrin and Infants’ Tylenol. In addition to the discovery of metal particles in the liquid medications, the drugs also had other manufacturing issues, including labeling problems and moldy odors.

The metal particles issue dates back to May 2009, when a customer found “black specks” in the bottom of a bottle of Infants’ Tylenol. After close inspection, the specks were determined to be particles of chromium and nickel. However, the company continued to sell the medications for months after finding the defect, before eventually issuing a recall.

At the time, the U.S. Food and Drug Administration concluded the chances of the defective medication causing a serious medical problem was unlikely, but still advised consumers to stop taking them.

In 2011, the FDA announced that it was taking over three of McNeil’s manufacturing facilities, including one in Puerto Rico and two in Pennsylvania. At the same time, the Agency and the Justice Department took action against McNeil PPC and two of its executives for failing to comply with federally-mandated manufacturing practices.

J&J suffers major sales decline

Johnson & Johnson’s U.S. consumer product sales dropped by more than 19 percent in 2010 — a drop of $900 million. The large amount of recalls in 2009 and 2010 largely contributed to the company’s first consecutive years of sales declines since World War II.

Carol Goodrich, a spokeswoman for McNeil Consumer Healthcare, said the plea agreement “closes a chapter” and that the company has “been implementing enhanced quality and oversight standards across its entire business.”

McNeil also noted the company agreed to take further safety measures prior to opening it’s new Fort Washington, Pennsylvania manufacturing facility. The plant where the defective Infants’ Tylenol and Children’s Motrin was made was shut down in 2010 and a new plant has been built.


  1. Reuters, Tylenol Maker to Pay $25 Million for Selling Metal-Contaminated Drugs http://www.reuters.com/article/2015/03/10/us-johnson-johnson-tylenol-idUSKBN0M629S20150310
  2. Health.com, Maker of Children’s Tylenol, Motrin to Plead Guilty to Selling Contaminated Medications http://news.health.com/2015/03/11/maker-of-childrens-tylenol-motrin-to-plead-guilty-to-selling-contaminated-medications/
  3. CNN Money, U.S. Takes Over Three Tylenol Plants http://money.cnn.com/2011/03/10/news/companies/johnson_mcneil_fda_action/