Alex Gorsky, CEO J&J

Mesh Medical Device News Desk, May 25, 2017 ~ For years, the healthcare giant has faced scrutiny over the cleanliness of its plants that produce its over-the-counter products.  

Now J&J must pay $33 million over its “deceptive practices.”

Fierce Pharma breaks the story this afternoon (here) of the $33 million fine Johnson & Johnson has agreed to pay over its recall of millions of bottles of over-the-counter children’s medicines and the substandard plants they came from.

J&M will pay the money to 42 states and the District of Columbia after an agreement with the New York Attorney General’s office.  The company must also reform its marketing practices. See it here. 

Years ago, Food and Drug Administration inspectors found contamination in the vats that produced Children’s Tylenol and Motrin, including metal particles, reports Time.com.

That led to a recall  in 2010 of over-the-counter products including Infants’ Tylenol and Children’s Motrin.   Here is a list of the items that were recalled.

In 2008 to 2010, millions of bottles of Tylenol, Motrin, Benadryl and other products made under the McNeil Consumer Healthcare banner. Not only metal particles but mold and labeling problems plagued the products.

As part of the agreement, J&J and its McNeil division, cannot say that its products meet acceptable Good Manufacturing Practices if a quality recall occurred over the past year.

Just two weeks ago, J&J resolved a similar case in the state of Oregon for $400,000. In that instance, J&J failed to announce a recall and instead sent undercover contractors into stores to retrieve the defective medications so the public wouldn’t know.

In 2008, the Food and Drug Administration conducted a series of inspections finding the Fort Washington, Pennsylvania plant found particulate contamination in the products. McNeil pled guilty and paid a $25 million fine.

Since then, the Pennsylvania plant has undergone $100 million in upgrades and reopened after it was shuttered by the FDA. ##