The Federal Service of Health Supervision informs about the decision to withdraw several drugs from circulation due to their non-compliance with regulatory requirements, Roszdravnadzor reports.
… “The drug “Ulcernil “produced by San Pharmaceutical Industries (India) due to the detection of the quality discrepancy of this series of drugs in stability tests according to the requirements of the regulatory documentation for the indicator” related impurities, “… preparation for inhalations “Budesonid-native manufactured by Nativa LLC (Russia) due to the detection of quality discrepancy according to the indicator” foreign impurities,… the drug “Dapson-Fatol, manufactured by SV Pharma GmbH (Germany) due to the detection of the quality discrepancy of the batch of this series of the drug according to the indicator” Quantitative determination, “” – said in the documents of the supervisory authority.
Also, based on information provided by BAIER JSC, the agency reports on the need to remove the Mirena drug of the TU02DU1 series, marked in Turkish. The supervisory authority also orders the withdrawal from market Yopromid drug, a solution for injections of 370 mg of iodine/ml 100 ml, manufactured by Novalek Pharmaceuticals India (owner of Jodas Expoim LLC), which does not meet the indicator “quantitative determination.”
The territorial bodies of Roszdravnadzor are ordered to ensure control over the removal from circulation of the above series of drugs. They must inform Roszdravnadzor about the carried out work.