Problems at a Janssen over-the-counter plant in Korea have gone from unfortunate to very serious now that authorities there intend to pursue criminal charges. This tack means Kim Oak-yeon, CEO of the Johnson & Johnson ($JNJ) subsidiary in South Korea, faces up to three years in jail if convicted.
Authorities seem to be keying in on the fact that the Janssen unit continued to sell Children's Tylenol after discovering it might contain more than the labeled amounts of acetaminophen, a problem that can lead to liver damage. There were no adverse reactions reported, The Korea Times reports.
"Despite being aware of the anomalies in March, it was a month before Janssen Korea notified us," Lee Dong-hee, director of the Ministry of Food and Drug Safety (MFDS) said at a news conference. In those four weeks, the company sold about 38,000 bottles of Children's Tylenol Suspension even though it potentially could cause liver damage, he said.
The MFDS has said that the company had manually filled containers with the ingredient because a filling machine wasn't working properly.
South Korean industry officials had already ordered the company to shut down manufacturing at the site. That has affected 5 products, The Korea Times reports. In addition to Children's Tylenol Suspension, it also includes the antidandruff medicine Nizoral, the prescription painkiller Ultracet, the stomach and bowel medicine Pariet, and attention deficit hyperactivity disorder medicine Concerta OROS.
CEO Kim said in a statement, "We apologize for causing concern regarding the recall of Children's Tylenol Suspension. We will cooperate with the authorities and make every effort to regain the trust of consumers, patients, medical experts and the government."
Problems in J&J's OTC unit in the U.S. created issues for the drugmaker for several years. In 2011, J&J's McNeil Consumer Healthcare signed an FDA consent decree after two years in which it recalled tens of millions of consumer products, including its popular Tylenol and Motrin products.
- read the Korea Times story