MFDS Confirms Dongindang Pharmaceutical's Violation of Pharmacist Act... Suspension of Manufacturing and Sales for 13 Items
[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety has decided to temporarily suspend the manufacturing and sales of 13 pharmaceutical products produced by Dongindang Pharmaceutical and has ordered their recall.
The products subject to suspension and recall include 12 items manufactured in-house and 1 item produced under consignment. The in-house manufactured items are ▲ Lobas Granules ▲ Kashut-san (Polystyrene Sulfonate Calcium) ▲ Kashut Suspension (Polystyrene Sulfonate Calcium) ▲ Phospho Tablets (Calcium Acetate) ▲ Dongindang Naproxen Tablets (Naproxen Sodium) ▲ Diobon 1000 Tablets ▲ Diobon Forte Tablets ▲ ND Suspension (Simethicone) ▲ Pyeon Tablets ▲ Phamsid Tablets 10 mg (Famotidine) ▲ Hanamax Tablets ▲ Healthy Calm S Tablets, totaling 12 products. The consignment manufactured product is Darim Biotech's 'Dicamax 1000 Tablets,' which is produced identically to Diobon 1000 Tablets.
This action follows the special inspection results by the 'Pharmaceutical GMP Special Inspection Team,' which confirmed violations of the Pharmaceutical Affairs Act by Dongindang Pharmaceutical, including ▲ unauthorized use of additives without approval ▲ no change in manufacturing methods ▲ arbitrary increase or decrease in raw material usage ▲ falsification of manufacturing records.
The Ministry of Food and Drug Safety has distributed a safety alert to medical professionals and consumer organizations, requesting cooperation to switch these 13 products to alternative medicines and to ensure proper product recall. The Ministry of Health and Welfare and the Health Insurance Review and Assessment Service have been asked to prevent prescriptions of these products at hospitals and clinics.
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The Ministry plans to continue operating the Pharmaceutical GMP Special Inspection Team to conduct unannounced inspections of pharmaceutical manufacturing sites throughout the year, prioritizing patient safety and promptly taking necessary measures.
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