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Daewon Pharmaceutical’s Jincheon plant. (Photo courtesy of Daewon Pharmaceutical) |
[Alpha Biz= Kim Jisun] The Ministry of Food and Drug Safety (MFDS) has issued recall orders for several pharmaceutical products manufactured by Daewon Pharmaceutical, Dongwha Pharm, Hana Pharm, and others after identifying impurities, labeling errors, and packaging defects.
According to the MFDS on the 24th, certain products were found to have a potential risk of exceeding acceptable levels of nitrosamine impurities. Nitrosamines, flagged by the International Council for Harmonisation (ICH) as potentially carcinogenic, can form during raw material synthesis or manufacturing processes.
Daewon Pharmaceutical’s thyroid medication Lepathine Tablet 25 mg was placed under a precautionary recall due to concerns that nitrosamine levels could surpass permitted limits.
Dongwha Pharm’s cholesterol medication Atostajet Tablets 10 mg and 20 mg was recalled following the discovery of labeling errors.
Dongkwang Pharmaceutical’s hypertension and arrhythmia treatment Indenol Tablet 10 mg (Propranolol Hydrochloride) will also be recalled due to potential nitrosamine excess. The recall covers 442 manufacturing batches produced between 2020 and December 2024, and the company has shortened the product’s shelf life from 60 months to 18 months. The shelf life of the non-recalled 40 mg strength has been similarly adjusted.
Hana Pharm’s cholesterol drug Rosto Tablet 5 mg (Rosuvastatin Calcium) was recalled due to the potential mix-up with Baladipine Tablets 5 mg and 80 mg, as both products are yellow tablets with similar appearance.
Mothers Pharmaceutical’s gastroesophageal reflux treatment Esopem Tablet 20 mg (Esomeprazole Magnesium Trihydrate) was recalled after defective packaging materials were found to potentially damage the tablets.
The MFDS stated that it will continue strengthening oversight of the manufacturing processes to ensure drug quality and public safety.
Alphabiz Reporter Kim Jisun(stockmk2020@alphabiz.co.kr)
