Ikigo cy’Igihugu gishinzwe kugenzura ubuziranenge bw’Imiti n’Ibiribwa, Rwanda FDA, cyakuye ku isoko imiti harimo ufite numero A4042 witwa EFFERARGAN VITAMIC C 500mg/200mg (“comprimé efferverscent), uzwiho kuvura umutwe.
Ni umuti wakozwe n’uruganda rwo mu Bufaransa, rwitwa UPSA SAS.
Icyemezo cyo kuwuhagarika cyafashwe nyuma y’ubusesenguzi ryakozwe n’Ikigo FDA.
Nyuma yo kuwugenzura ngo basanze nimero yawo yarahinduye ibara riba iry’ikigina mu mwanya wo kuba ibara ry’umweru, ibyo nk’uko byagaragajwe mu itangazo ryashyizweho umukono n’Umuyobozi Mukuru wa FDA Prof Emile Bienvenue, bikaba bihabanye n’ibipimo by’ubuziranenge ugomba kuba wujuje.
Undi muti uvura zimwe na zimwe z’amaso wahagaritswe ni uwitwa TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% W/W STERILE ufite nimero 23038, ukorwa n’uruganda rwitwa Curis Lifescience Pvt Ltd rwo mu Buhinde.
Ikigo FDA muri raporo zagiye zikorwa zigashyikirizwa Ikigo FDA nacyo kikaziheraho gikora ubusesenguzi, cyasanze ibara rya nimero y’uyu muti naryo ryarahindutse umukara aho kuba ibara ry’igikina, ibyo bikaba bihabanye n’amategeko ngenderwaho y’ibipimo byawo by’ubuziranenge.
Abaganga n’abahanga mu by’imiti, abakoresha imiti, abafite ububiko bw’imiti n’amashami yabo yose, abinjiza imiti mu gihugu, Farumasi ziranguza n’izidandaza, amavuriro ya Leta n’ayigenga byo mu gihugu hose, byamenyeshejwe mu itangazo ryasohotse tariki 30 Kamena 2024, ko izo nimero z’imiti zihagaritswe.
Itangazo rya FDA kandi rivuga ko bitemewe kuzikoresha no kuzikwirakwiza, ahubwo ko bagomba kwihutira kuyisubiza aho yaturutse.
Iki kigo cyanamenyesheje abo bireba bose ko hagomba gukorwa raporo igizwe n’imibare y’ingano y’umuti waranguwe, iyagurishijwe, iyagaruwe ndetse n’itaracurujwe.
Ibyo bigakorwa mu gihe kitarenga iminsi 10 y’akazi uhereye igihe itangazo ryasohokeye ndetse iki kigo kiboneraho no kuburira abantu bari baratangiye kuyikoresha nyuma yo kuyandikirwa na muganga, kureka gukomeza kuyikoresha.
