US healthcare major Johnson & Johnson (J&J), which has been struggling with manufacturing issues since the past three years, is recalling children's Tylenol products in South Korea because they contained an overdose of the medicine.
Over the weekend, J&J's subsidiary Jansen recalled its Children's Tylenol Suspension 100-ml and 500-ml bottles since they contained excessive levels of acetaminophen, which could lead to liver damage.
A spokesperson for the New Jersey-based company said that quality control tests had revealed that a few bottles of this over-the-counter medicine contained more than the prescribed amount of acetaminophen.
South Korea's Ministry of Food and Drug Safety (MFDS) said in a statement that the recall was issued after Janssen violated several regulations, including not reporting the problem quickly, delaying the recall by a month and flouting quality-control regulations.
An audit by MFDS revealed that the company had manually filled containers with acetaminophen since a filling machine was not working.
The recall comes in the same week when Indian health officials revoked J&J's licence to manufacture cosmetics at a plant in Mumbai after finding that the company had used a dangerous and unauthorised process for sterilising baby powder (See: Johnson & Johnson's plant licence revoked on quality concerns).
J&J has issued a series of product recalls across a wide range of products over the past three years due to manufacturing-quality problems that have cost the company more than $3 billion
It has recalled millions of bottles of over-the-counter products such as Motrin and children's Tylenol and other products like contact lenses, joint-replacement parts, surgical wound draining products, insulin pump cartridges, Rolaids Extra Strength Softchews among others.
Apart from this the company is facing several lawsuits ranging from kickbacks to a company that dispenses drugs to nursing homes to faulty hip ASR implants.
J&J is operating under continuous scrutiny by the US Food & Drug Administration, the Congress and federal prosecutors over its several recalls, and has signed a consent decree with the US regulators to oversee some manufacturing.