Janssen's Manufacturing Problems May Lead to Criminal Charges in Korea
The South Korean Ministry of Food and Drug Safety (MFDS) recently ordered Janssen – a subsidiary of Johnson & Johnson - to recall about 1.67m bottles of its Children’s Tylenol Suspension made at the Hyang Nam facility, due to excessive levels of the active ingredient acetaminophen which could cause liver damage.
Though a temporary production suspension has been imposed on several products at the facility, Janssen spokesperson Jennifer Tear told in-Pharmatechnologist.com “that the manufacturing processes at the facility will be remedied as soon as possible."
According to the Korea Times, the MFDS discovered that malfunctions in recently purchased equipment led to some bottling being done by hand risking up to 50 per cent extra acetaminophen being added to products in March and April this year.
As such, the MFDS declared Janssen’s plant was in breach of GMP (good manufacturing practices) as the company did not notify the regulatory body of this change in manufacturing process.
“We are confident that the concerns of the Korean authorities can be addressed, bringing about the earliest possible resolution of the situation,” said Tear.
She added: “Our immediate priority is restoring the trust and confidence of patients, healthcare professionals and regulatory authorities.”
The MFDS has ordered a five month suspension of Children’s dye-free Tylenol, a four month suspension of its antifungal shampoo Nizoral, and a one-month suspension for production of its ADHD drug Concerta, painkiller Ultracet and anti-ulcer drug Pariet.
However, Tear told us Tylenol remains the only drug at the subject of a recall in Korea and that manufacture of all other products at the site were unaffected by this lapse in quality.
Suspended Production, Custodial Sentence
In a press conference, Director of the MFDS, Lee Dong-hee, explained the severity of the situation. “Despite being aware of the anomalies in March, it was a month before Janssen Korea notified us,” he said, as reported in the Korea Times.
As such, the Korean government has filed a criminal complaint against Janssen for manufacturing and selling dangerous medicine, especially as the product was to be consumed by those under the age of 12.
Such a prosecution could see Janssen Korea’s CEO Kim Oak-yeon face up to three years in prison, if the company is found guilty under Korea’s Pharmaceutical Affairs Law.
