A series of recent drug mispackaging incidents have put the manufacturing process management of domestic pharmaceutical companies under scrutiny.
This time, the mix-up incident involved a dyslipidemia drug produced by Daewon Pharmaceutical. The incident's aftermath will be closely watched as Daewon produces items with the same ingredients.
The Ministry of Food and Drug Safety said Tuesday that a recall of some manufacturing numbers (23RT1003) of Dongkook Pharmaceutical's Rosutanzet Tablet 10/10mg is underway. The recall is due to some other products being mixed in. Dongkook has initiated a voluntary recall.
Rosutanzet is a drug that treats dyslipidemia by combining ezetimibe and rosuvastatin. Hanmi Pharm's 'Rosujet' represents the same combination of ingredients. Dongkook Pharmaceutical is the licensee of Rosutanzet, but Daewon Pharmaceutical produces it at its plant in Hwaseong, Gyeonggi Province.
The problem is that Daewon produces not only Dongkook's Rosutanzet tablets but also some other products of similar ingredients, like its Clowzet Tablet 10/10mg, Sam Chun Dang Pharmaceutical's Rozelow Tablet 10/10mg, and Ahngook Pharmaceutical's Suvazet Tablet 10/10mg. All of them are combinations of ezetimibe and rosuvastatin and are manufactured at the same factory of Daewon in Hwasung.
Depending on the scale of the incident, recall measures may be expanded, as workers can mispackage drugs with the same ingredients and different labels in the wrong containers. In some cases, it will spark other consignors than Dongkook.
The ministry has not disclosed any administrative penalties or other measures for the mix-up incident. In May, Daewon voluntarily recalled and refunded its children's antipyretic pain reliever, Col Daewon Kids Pen Syrup, due to phase separation.
This is not the first drug mispackaging incident this year. The pharma industry has recently been criticized for drug contamination incidents.
In August, Theragen Etex recalled Celltrion Pharmaceutical's aspirin in a container with the same ingredient as a brand-name drug item of Myungmoon Pharm, and Korus Pharm controversially labeled its cephalosporin antibiotic Korus Cefaclor Capsule 250mg with a different packaging unit.
Earlier, in June, Hyundai Pharmaceutical was criticized for distributing its dementia drug Tamirine Tablets 8mg (galantamine bromide) in the packaging of its hypertension drug Hyundai Minoxidil Tablets (minoxidil).
The Citizens United for Consumer Sovereignty issued a position paper later.
It criticized the domestic pharmaceutical industry for frequent drug mix-ups that threaten the health of patients and consumers, urging the industry to self-reflect and the regulator to work out active measures.