The Ministry of Food and Drug Safety said Wednesday said that it has ordered the recall of Kwangdong’s Arucen Inj., an antipyretic-analgesics, for containing a minute foreign substance of black color.
Kwangdong outsourced the contaminated batch of Arucen ordered for recall to Samsung Pharmaceutical.
Samsung manufactured the batch at its plant in Hwaseong, Gyeonggi Province.
Concerning the detection of the foreign substance in the drug product, the ministry plans to investigate the whole factory such as its good manufacturing practice (GMP) regulations, and will take measures such as administrative disposition if it finds any violations.
The ministry has ordered the stoppage of the manufacturing and marketing of the product until it has completed investigations. It also asked anyone who experienced side effects of the product to report their symptoms to the Korea Institute of Drug Safety & Risk Management.
Samsung Pharma also had a recall in 2016 when the ministry found food poisoning bacteria in Sulbacillin Inj. 1.5g and 750mg, penicillin antibiotics outsourced by Daweoong Pharmaceutical, and Samsung’s Bacillin Inj. 1.5g and 750mg.
At that time, Daewoong, which had commissioned the manufacture, informed the ministry that it would voluntarily recall the product.
The company also found tainted antibiotic injections after replacing its heating, ventilation, and air conditioning system in January of that year.
It is not uncommon to see food poisoning bacteria within aseptically produced injectable products.
“There has been no definite conclusion that there is a problem in the manufacturing process yet,” a Samsung Pharmaceutical company official told Korea Biomedical Review.