MFDS Suspends Manufacturing and Sales of 6 Items Including Onjanghwan by Hanguk Syntex Pharmaceutical

The Ministry of Food and Drug Safety announced on the 7th that it has temporarily suspended the manufacture and sale of six products, including ‘Onjanghwan’ (digestive medicine) manufactured and sold by Hanguk Syntex Pharmaceutical, and has initiated a recall.

The six recalled products include Onjanghwan, Syntex Yeonnyeon Iksu Bulrodan, Syntex Cheongsinhwan (Yeonrahwan), Wireokhwan (Hyangsapyeongwisan), Syntex Cheonggihwan (Cheonwangbosimdan), and Yeongsuhwan.

According to the Ministry, violations of the Pharmaceutical Affairs Act were found, such as arbitrarily changing additives during the manufacturing process of these products by Hanguk Syntex Pharmaceutical and falsifying manufacturing records.

This suspension of manufacture and sale will remain in effect until Hanguk Syntex Pharmaceutical completes necessary safety measures such as recalls and product modification approvals (notifications).

The Ministry of Food and Drug Safety has ordered that tests and inspections be conducted at testing institutions designated by the Minister of Food and Drug Safety to verify the quality appropriateness of the six products and that the results be submitted.

Following this measure, the Ministry recommended that doctors and pharmacists suspend prescribing and administering these six products, and advised patients currently taking them to consult medical and pharmaceutical experts. Additionally, it announced that a ‘Drug Safety Bulletin’ containing requests for cooperation to ensure the prompt recall of the products has been distributed to related organizations.

This content was produced with the assistance of AI translation services.