Tylenol troubles Janssen Korea

By Bahk Eun-ji

The state food watchdog said Friday that it is widening its investigation into Janssen Korea over its manufacturing process for Tylenol syrup products for children.

The Ministry of Food and Drug Safety (MFDS) banned prescriptions for and sales of Childrens Tylenol Suspension 100 ml and 500 ml made by Janssen Korea on Tuesday because of possible increased concentration of an active ingredient.

The key ingredient in the syrup product is acetaminophen and its possible that 20 to 50 percent more was added to products manufactured during March 18 to April 19, an MFDS official said. Excessive intake of the substance can damage the liver.

The MFDS said it is examining Janssen Koreas production process and quality control. The ministry has already established that Janssen Korea did not abide by Good Manufacturing Practices (GMP).

We are widening the scope of our investigation to include the overall management system of Janssens manufacturing plant in Hwaseong in Gyeonggi Province, said the MFDS official.

Jansen Korea purchased new equipment in 2011, but the equipment malfunctioned, causing equal amounts of medicine to be put into bottles, so the company then performed that part of the process by hand.

The ministry says that excessive amounts of acetaminophen may have been put in during this stage of the process.

According to the GMP, pharmaceutical firms have to notify the MFDA if they change their manufacturing process, but Janssen Korea failed to do this, said ministry officials.

We found out a bottle of medicine with a problem for the first time on March 18. Shortly after this was found, we checked other samples until April 19 to check if they have the same problem, said a spokeswoman for Jansen Korea.

The ministrys investigation is focused on why Janssen Korea released the products from March 18 to April 19, if they were aware of the problem.

However, Janssen Koreas spokeswoman said the products released during this period passed the quality test before any problem was found.

We decided to recall all the products to protect consumers, although the defective products took up only 0.17 to 0.33 percent of output. We apologize for this incident to our customers and will make an official statement as soon as the MFDS finishes its investigation, the spokeswoman said.

The ministry said that the recall order is a safety measure to prevent anyone taking too much acetaminophen.