GMP Violations Confirmed-Distribution of “Pharmaceutical Safety Alert” to Healthcare Professionals, Physicians, and Pharmacists.
On February 27th, the Ministry of Food and Drug Safety (2025년 슬롯사이트) announced the temporary suspension of manufacturing and sale of 'Loxoris Tablets (active ingredient: sodium ibuprofen hydrate)' for fever, pain, and inflammation, and 'Glipa M Tablets 2/500 mg' for diabetes, produced and sold by DongKoo BioPharm.
This decisive action comes in the wake of an inspection conducted by 2025년 슬롯사이트, evaluating DongKoo BioPharm's adherence to Good Manufacturing Practice (GMP) standards and other regulatory criteria. The inspection exposed violations of the Pharmacy Act, including unauthorized alterations to additives during the manufacturing process, deviating from approved specifications, and fraudulent entries in the manufacturing records, falsely indicating compliance with approved specifications.
The suspension of manufacturing and sales will persist until DongKoo BioPharm completes necessary safety measures, which include recall procedures and obtaining approval for product modifications. In response to these findings, the 2025년 슬롯사이트 has instructed DongKoo BioPharm to furnish the results of quality assessments for the two products through testing institutions designated by the Director of 2025년 슬롯사이트.
In light of these developments, the 2025년 슬롯사이트 strongly recommends healthcare professionals to halt the prescription and preparation of the affected products. Patients currently using these medications are advised against discontinuing them without consulting their healthcare provider. Furthermore, a 'Pharmaceutical Safety Alert' has been disseminated to healthcare professionals, urging their collaboration in expediting the recall of the implicated products.
An official statement from the 2025년 슬롯사이트 underscores their commitment to ongoing and rigorous inspections of pharmaceutical manufacturers and importers. This commitment is aimed at ensuring the continued distribution of safe medications, with the official emphasizing, "We will continue to conduct regular inspections to uphold pharmaceutical safety standards and address any non-compliance promptly."