The two recalled types of Children's Tylenol Syrup contained excessive amounts of acetaminophen, the active ingredient in Tylenol, and could result in liver damage. Janssen Korea neglected to report its production process changes from an all-automated system to a dual system that requires the incorporation of both automatic and manual processes. Furthermore, according to the Korean ministry, Janssen Korea neglected to not only report its safety problems to the ministry for approximately one month, but also conduct quality control inspections of its manufacturing process.
Pharmaceutical Affairs Law stated that, in cases of manufacturing errors, companies face between 1-6 months of production suspension. Janssen Korea is seeking assistance from its head offices to resolve the manufacturing problems.
Janssen to Halt Tylenol Production
J&J Halts Tylenol Production In South Korea Over Mishap