MFDS Suspends Manufacturing and Sales of 3 Products by Hansol Pharmaceutical

Special Inspection Results of the Pharmaceutical GMP Special Planning Inspection Team

Source=MFDS

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 2nd that it will temporarily suspend the manufacture and sale of three products, including 'Geungolhwan,' produced by the pharmaceutical manufacturer Hansol Shinyak, and initiate a recall.

This measure follows the findings of the 'Pharmaceutical GMP Special Inspection Team,' which conducted a special inspection of Hansol Shinyak and confirmed violations of the Pharmaceutical Affairs Act, including ▲ arbitrary increase or decrease in raw material usage or arbitrary use of additives without filing a change report ▲ no change in manufacturing methods ▲ falsification of manufacturing records.

The Ministry of Food and Drug Safety has issued a safety alert requesting experts' cooperation to discontinue the use of the three products, switch to alternative medicines, and properly carry out the recall of distributed products, distributing this alert to medical professionals, pharmacists, and consumer organizations.

The Ministry stated, "Going forward, the Pharmaceutical GMP Special Inspection Team will conduct unannounced inspections of pharmaceutical manufacturing sites throughout the year, prioritizing patient safety and promptly taking necessary measures."

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