The Ministry of Food and Drug Safety ordered recalls after impurities, label errors, and packaging problems were found in some medicines made by pharmaceutical companies including Daewon Pharmaceutical, Dongwha Pharm, and Hana Pharm.
According to the Ministry of Food and Drug Safety on the 24th, it was confirmed that some products could show nitrosamine impurities above the standard. Nitrosamines are substances warned by the International Council for Harmonisation (ICH), an international regulatory body, as potentially carcinogenic, and can arise during raw material synthesis or the manufacturing process.
First, Daewon Pharmaceutical's thyroid treatment Repatjin tablet 25 mg was designated for a preventive recall over concerns that nitrosamine impurities could exceed the permitted level. Dongwha Pharm's hyperlipidemia treatment Atostazet tablet 10·20 mg was included in the recall after a label marking error was found.
Dongkwang Pharm's hypertension and arrhythmia treatment Indenol tablet 10 mg (propranolol hydrochloride) will also be recalled over concerns of exceeding the impurity limit. The recall applies to a total of 442 lot numbers manufactured from 2020 to Dec. 2024, and along with the recall, Dongkwang Pharm shortened the shelf life of Indenol tablet 10 mg from 60 months to 18 months. The shelf life of the 40 mg product, which is not subject to recall, was changed in the same way.
Hana Pharm's hyperlipidemia treatment Rosto tablet 5 mg (rosuvastatin calcium) will be recalled over concerns of mixing with another product, Valadipin tablet 5·80 mg. Both products are yellow tablets and have a similar appearance, raising the possibility of confusion.
Mothers Pharmaceutical's gastroesophageal reflux disease treatment EsOPM tablet 20 mg (esomeprazole magnesium trihydrate) entered recall due to the possibility of tablet damage caused by defective packaging materials.