[라포르시안] As a result of checking Unimed Pharmaceuticals, the Ministry of Food and Drug Safety confirmed the possibility of microbial contamination throughout the manufacturing facility for injections, and has suspended provisional manufacturing and sales (including prescription and use) of all five products produced in the manufacturing facility.24 Sun said.
In addition, for three items of aseptic manipulation injections, all serial numbers were collected. Aseptic operation is a manufacturing method in which all instruments and materials to be used are sterilized in advance, and then environmental microorganisms and fine particles are maintained in a sterile state in a facility that is properly managed.
On the 11th, the Ministry of Food and Drug Safety confirmed the possibility of microbial contamination in the manufacturing process of injections and the entire manufacturing facility by investigating related products and the plant as it was confirmed that the sterility test of 15 milligrams of Unialju (sodium hyaluronate) was not suitable. Sterility verification before product production, such as measures to prevent contamination of sterile raw materials and sterilization of instruments and machines, was insufficient.
 |
The Ministry of Food and Drug Safety has distributed a safety bulletin to experts, such as medical and pharmacists, to convert the product to other alternative medicines and request cooperation so that product recall can be performed properly. In addition, through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, it requested hospitals and clinics to restrict prescriptions for the product.
The Ministry of Food and Drug Safety requested that any abnormal signs such as the occurrence of side effects suspected of being related to the product should be immediately reported to the Korea Pharmaceutical Safety Management Agency.
Reporter Park Jin-kyu [email protected]
<저작권자 © 라포르시안, 무단 전재 및 재배포 금지>