Watchdog to press charges against Janssen Korea

South Korea's food watchdog said Thursday that it will bring criminal charges against Janssen Korea Ltd. over safety concerns about Tylenol syrup products in addition to banning the pharmaceutical company from producing the medicine for five months. The local unit of Janssen Pharmaceuticals Inc. offered an apology and vowed to cooperate with the South Korean authorities to restore public confidence. The move came three weeks after the Ministry of Food and Drug Safety ordered Janssen Korea to recall and discard about 1.67 million bottles of Children's Tylenol Suspension produced after May 2011. The food watchdog said some Tylenol syrup products contained more acetaminophen, a key ingredient in relieving pain and fever, than they should have. The problem occurred as Janssen Korea's workers manually put Tylenol syrup into bottles as new automated facilities installed in May 2011 could not completely fill up the bottles at the end of the manufacturing process, according to the food watchdog and Janssen Korea. The U.S. Food and Drug Administration warned on its Web site that acetaminophen can cause serious liver damage if more than directed is used. Kwak Chae-woon, a Janssen Korea official, said his company has so far recalled about 200,000 bottles as the rest were already used, though he said there have been no reports of side effects. The food watchdog also said it plans to impose ban on the production of Nizoral, an anti-dandruff lotion, for four months in addition to one-month bans on the production of a painkiller, a stomach medicine and a medicine designed to treat attention deficit hyperactivity disorder. The production ban could take effect within a month due to administrative processes, according to the food watchdog. The food watchdog also said it plans to complete its component analysis for the five medicines and 34 others that are produced and sold in South Korea by Janssen Korea by June. Janssen Korea said it will quickly improve the manufacturing process at its plant in Hwaseong, some 60 kilometers south of Seoul. Kim Oak-yeon, CEO of Janssen Korea, said her company will use the latest incident as an occasion to make better medicines and improve quality control. "We will cooperate with the investigation by related authorities to try to regain the confidence of consumers, patients, medical professionals and the government," she said in a statement.