The Agency for Disease Control and Prevention confirms that the quality inspection result is not suitable and cancels the permit on February 4
UniMed Pharmaceutical’s approval for three items, such as’Unialju 15mg (sodium hyaluronate)’,’Hyalondispimp’ and’Unilondispimp’, used for maintaining eye shape during cataract surgery, has been revoked.
The Korea Centers for Disease Control and Prevention (KCDC) announced on the 28th that it will cancel the permission on February 4th as an administrative disposition for violation of Article 62 of the Pharmaceutical Affairs Act after confirming that the above three items were not suitable as a result of quality (sterility test) inspection with the Ministry of Food and Drug Safety. .
Unialju 15mg is a mucous elastic material that is used for maintaining eye shape and protecting corneal epithelial cells during cataract surgery and removed at the end of surgery.
Based on 146 cases in which the hospital was transferred to a superior ophthalmology hospital for the treatment of fungal endophthalmitis after cataract surgery in September-November last year, the Korean Agency for Disease Control and Prevention confirmed individual cases.
An official from the Agency for Disease Control and Prevention said, “As a result of the investigation of cases of fungal endophthalmitis after cataract surgery, it was confirmed that 136 cases, or 93.2%, used the item.” As a result of culturing samples of 42 patients with endophthalmitis, all of the fungi, Fusarium spp., were identified.”
Earlier, in December of last year, the Ministry of Food and Drug Safety ordered the temporary suspension of manufacturing and sale of the three items and the recall of all products. In addition, it is known that administrative procedures such as hearings have been conducted in order to cancel the permission for the item due to non-conformity of the quality inspection.
An official from the Ministry of Food and Drug Safety said, “We will do our best to ensure the distribution of pharmaceuticals with secured quality by more thorough management and supervision of pharmaceutical manufacturers and importers.”
Copyright owner © Doctor Shinmun Unauthorized reproduction and redistribution prohibited