Johnson & Johnson Unit Pleads Guilty for Knowingly Selling Tainted Children's Tylenol
Published: Mar 12, 2015
March 11, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson , pleaded guilty in a federal court on March 10 to selling over-the-counter infant’s and children’s medicine that contained metal particles. The Pennsylvania company failed to correct the matter after finding that bottles of Infants’ and Children’s Tylenol and Children’s Motrin had nickel, iron and chromium in them. Now, McNeil has agreed to pay $25 million to resolve the lawsuit.
The investigation began after the company began recalling a number of products between 2008 and 2010. The recalls, however, were not because of safety risks to consumers, according to Johnson and Johnson.
"This plea agreement fully and finally resolves the federal government's investigation, and closes a chapter on actions that led the company to review and significantly improve its procedures," said Carol Goodrich, a spokesperson for McNeil Consumer Healthcare. "McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are best able to meet our commitment to consumers, patients and doctors who rely on our products."
McNeil was eventually able to trace its problems to machinery in its plant in Fort Washington, Penn., according to the Associated Press. This plant has also been linked to several recalls of Tylenol and other drugs for both adults in children.
Dosing Instructions Encourage a Recall
In February 2012, McNeil voluntarily decided to recall Infants’ Tylenol Oral Suspension, 1 oz., as a result of complaints linked to dosing instructions. Some consumers reported difficulty using the Tylenol SimpleMeasure dosing system, which includes a syringe.
While the company noted that there were no adverse effects associated with the reports, the recall applied to approximately 574,000 bottles of the over-the-counter medicine.
Reports of Odor Evoke a Recall
In June 2011, McNeil chose to voluntarily recall its Tylenol Extra Strength Caplets (225 count bottles) after individuals began reporting a musty, moldy odor. These products were manufactured back in February 2009.
The odor was eventually traced to trace amounts of a chemical known as 2,4,6-tribromoanisole. In some cases, it has been linked to temporary, non-serious gastrointestinal symptoms. However, the company noted that adverse medical events from this chemical are remote.
Both recalls were conducted with the knowledge of the U.S. Food and Drug Administration (FDA), and McNeil encouraged consumers to report their findings to the FDA.
BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?