By Kim Jae-won
Janssen Korea may be ordered to suspend the production of two types of Tylenol syrup for children after the authorities found that the Korean unit of the U.S.-based drug maker violated pertinent regulations.
The scope of punishment could also be expanded, depending on the outcome of an ongoing special investigation. The two drugs account for 16 percent of the local market, amounting to 21.4 billion won in sales.
The Ministry of Food and Drug Safety (MFDS) said Janssen violated multiple regulations during its manufacturing of the syrup.
The ministry ordered the company to recall all of the two products on the market last week, as they potentially have an excessive amount of acetaminophen, which could cause liver damage.
"Janssen Korea violated two rules during its production process of Children's Tylenol Suspension 100ml and 500ml," said Kim Mi-kyeong, the ministry spokesman.
Kim said that usually pharmaceutical companies are prohibited from producing drugs for several months when problems are detected related to manufacturing.
According to the Pharmaceutical Affairs Law, companies face one to six months of production suspension, depending on the type of problem.
The ministry said that Janssen Korea violated at least three production rules.
"Janssen Korea did not report its safety problems to the ministry as soon as possible, delaying it for a month. It also did not conduct quality control inspections of its manufacturing process," said the ministry in a statement.
The ministry said that Janssen also did not report that it changed its production process from an all-automated to a dual system that uses both automated and manual processes.
Observers say that sanctions, if implemented, will hit the company seriously by tarnishing its brand image and reputation.
Janssen Korea is a mid-sized pharmaceutical company here, which posted 2.6 billion won in net profit last year, according to data from the Financial Supervisory Service.
Meanwhile, Janssen said it was closely coordinating with its headquarters on the matter.
"We reported the case to our headquarters. Some technical experts from our head office came to our factory and are working with us to resolve all problems," said Kim Jee-young, a director of the company.