國(guo)家(jia)藥監局(ju)發布通告稱,經11家(jia)藥品(pin)檢(jian)驗機構檢(jian)驗,40家(jia)企(qi)業生產的57批次藥品(pin)不(bu)符合(he)規(gui)定(ding)。藥品(pin)監督管理(li)部(bu)門已要求相(xiang)關(guan)企(qi)業和單位采(cai)取暫(zan)停銷(xiao)售使用、召回(hui)等風險控制措施,對不(bu)符合(he)規(gui)定(ding)原因開展(zhan)調查并切實進行整(zheng)改。
國家藥監局于2019年11月26日發布通(tong)告稱,經11家(jia)藥品檢驗機(ji)構檢驗,標(biao)示為康(kang)普藥業股份有(you)限公司等40家企業生產的57批次(ci)藥品不符合規定。
國(guo)家藥監(jian)(jian)局表示,對(dui)不符合規定的藥品(pin),藥品(pin)監(jian)(jian)督管理部門已要(yao)求相關企業和(he)單位采取暫停銷售使(shi)用、召回等(deng)風險控制措施,對(dui)不符合規定原因開展調查并切實進行整改。
國家藥監局要求相關省級藥品監督管理部門依據《中華人民共和國藥品管理法》組織對這40家企業和單位生(sheng)產銷售(shou)假劣藥品的違法行(xing)為(wei)立(li)案調查(cha),自收(shou)到(dao)檢驗報告書之日起3個月內(nei),完成對(dui)相關(guan)企業或單位的調查處理并公開結(jie)果。
另外(wai),在(zai)立案(an)調查工(gong)作(zuo)中,企(qi)業對(dui)產(chan)品真實(shi)性有(you)異議的,可以向所(suo)在(zai)地(di)(di)省級(ji)藥品監督管(guan)理部門(men)提出。標(biao)示生產(chan)企(qi)業所(suo)在(zai)地(di)(di)省級(ji)藥品監督管(guan)理部門(men)應對(dui)該企(qi)業的生產(chan)銷售情況進行調查核實(shi),被抽樣單位所(suo)在(zai)地(di)(di)省級(ji)藥品監督管(guan)理部門(men)應追溯(su)問題(ti)產(chan)品來(lai)源;兩地(di)(di)藥品監督管(guan)理部門(men)要相互(hu)配合、及時通報、一查到(dao)底(di),并將相關工(gong)作(zuo)情況按要求及時上報。
以下是通告內容:
經蘇州市(shi)藥(yao)品檢(jian)驗(yan)(yan)檢(jian)測研究(jiu)中(zhong)心(xin)檢(jian)驗(yan)(yan),標示(shi)為康(kang)普藥(yao)業股(gu)份有限公(gong)司生產的5批次阿魏酸哌嗪(qin)片不符合規(gui)定(ding),不符合規(gui)定(ding)項目為性狀。
經北京市藥(yao)品(pin)檢驗所檢驗,標示為江蘇聚榮(rong)制藥(yao)集(ji)團有限(xian)公司生(sheng)產的(de)3批次葡萄糖酸鈣口服溶(rong)液不符(fu)合規(gui)定,不符(fu)合規(gui)定項(xiang)目為性狀。
經重(zhong)慶市食品(pin)藥(yao)品(pin)檢驗(yan)檢測研(yan)究院檢驗(yan),標示(shi)為山西國潤制(zhi)藥(yao)有限公司生(sheng)產的2批次吸入用乙酰半胱氨酸(suan)溶液不符合規定,不符合規定項目包括硫化氫(qing)、有關物質。
經西(xi)藏自治(zhi)區食品(pin)藥品(pin)檢驗研究院(yuan)檢驗,標示為(wei)湖南亞大制藥有限(xian)公司生產(chan)的1批次(ci)鹽酸(suan)乙哌立松片(pian)不符(fu)合(he)規定(ding),不符(fu)合(he)規定(ding)項目為(wei)有關物質。
經(jing)新疆維吾爾自治區(qu)食品藥(yao)品檢驗(yan)所檢驗(yan),標(biao)示(shi)為廣西(xi)梧州三箭制藥(yao)有限公司生產的(de)1批次(ci)感冒止咳糖漿不符(fu)合(he)規定(ding),不符(fu)合(he)規定(ding)項目為含量測定(ding)。
經安徽省(sheng)食品藥(yao)品檢驗(yan)研究院檢驗(yan),標示為亳州(zhou)中(zhong)(zhong)強中(zhong)(zhong)藥(yao)飲片有(you)限(xian)公(gong)(gong)司(si)(si)生(sheng)產(chan)的1批次補(bu)骨脂(zhi)(zhi)不符(fu)(fu)合規定,標示為亳州(zhou)中(zhong)(zhong)強中(zhong)(zhong)藥(yao)飲片有(you)限(xian)公(gong)(gong)司(si)(si)、黑龍江千(qian)盛藥(yao)業有(you)限(xian)公(gong)(gong)司(si)(si)、新疆本草堂藥(yao)業有(you)限(xian)公(gong)(gong)司(si)(si)生(sheng)產(chan)的3批次補(bu)骨脂(zhi)(zhi)(鹽補(bu)骨脂(zhi)(zhi))不符(fu)(fu)合規定,不符(fu)(fu)合規定項(xiang)目(mu)為含量(liang)測定。
經四(si)川省食品藥(yao)品檢(jian)(jian)驗檢(jian)(jian)測院檢(jian)(jian)驗,標示為(wei)(wei)(wei)江(jiang)(jiang)蘇(su)(su)蘇(su)(su)軒堂(tang)(tang)藥(yao)業(ye)(ye)有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、江(jiang)(jiang)蘇(su)(su)百草(cao)中(zhong)(zhong)藥(yao)有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、安徽致良中(zhong)(zhong)藥(yao)飲片有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、安徽濟善堂(tang)(tang)中(zhong)(zhong)藥(yao)科技有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、南(nan)城縣(xian)建洪中(zhong)(zhong)藥(yao)飲片廠(chang)、湖北天濟中(zhong)(zhong)藥(yao)飲片有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、河北國(guo)松堂(tang)(tang)制藥(yao)有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、江(jiang)(jiang)蘇(su)(su)華(hua)洪藥(yao)業(ye)(ye)科技有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、廣西(xi)藍(lan)正(zheng)藥(yao)業(ye)(ye)有(you)(you)限(xian)(xian)(xian)責任(ren)公(gong)(gong)司(si)(si)(si)、新疆本草(cao)堂(tang)(tang)藥(yao)業(ye)(ye)有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、甘肅省國(guo)草(cao)藥(yao)業(ye)(ye)有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、江(jiang)(jiang)西(xi)樟(zhang)樹天齊(qi)堂(tang)(tang)中(zhong)(zhong)藥(yao)飲片有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)、四(si)川博仁藥(yao)業(ye)(ye)有(you)(you)限(xian)(xian)(xian)責任(ren)公(gong)(gong)司(si)(si)(si)、江(jiang)(jiang)西(xi)樟(zhang)樹國(guo)康(kang)中(zhong)(zhong)藥(yao)飲片有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)等(deng)企(qi)業(ye)(ye)生(sheng)(sheng)產的18批(pi)次半夏(xia)(xia)(法半夏(xia)(xia))不(bu)符(fu)(fu)合(he)規(gui)定(ding),標示為(wei)(wei)(wei)昆明道(dao)地(di)中(zhong)(zhong)藥(yao)飲片廠(chang)生(sheng)(sheng)產的1批(pi)次半夏(xia)(xia)(姜半夏(xia)(xia))不(bu)符(fu)(fu)合(he)規(gui)定(ding),標示為(wei)(wei)(wei)安徽匯中(zhong)(zhong)州中(zhong)(zhong)藥(yao)飲片有(you)(you)限(xian)(xian)(xian)公(gong)(gong)司(si)(si)(si)等(deng)企(qi)業(ye)(ye)生(sheng)(sheng)產的2批(pi)次半夏(xia)(xia)(清半夏(xia)(xia))不(bu)符(fu)(fu)合(he)規(gui)定(ding),不(bu)符(fu)(fu)合(he)規(gui)定(ding)項目包括性(xing)狀(zhuang)、鑒別、浸出物、水(shui)分。
經中國食(shi)品藥(yao)(yao)品檢(jian)定研究院檢(jian)驗(yan),標示為安徽方氏制藥(yao)(yao)有(you)(you)限(xian)公(gong)司(si)(si)(si)、安徽戊(wu)庚中藥(yao)(yao)飲片(pian)有(you)(you)限(xian)責任(ren)公(gong)司(si)(si)(si)、安徽友(you)信藥(yao)(yao)業(ye)(ye)有(you)(you)限(xian)公(gong)司(si)(si)(si)、亳州中強中藥(yao)(yao)飲片(pian)有(you)(you)限(xian)公(gong)司(si)(si)(si)、內蒙古啟明中藥(yao)(yao)飲片(pian)有(you)(you)限(xian)公(gong)司(si)(si)(si)、成都(dou)市(shi)益(yi)誠藥(yao)(yao)業(ye)(ye)有(you)(you)限(xian)公(gong)司(si)(si)(si)、甘(gan)肅省國草藥(yao)(yao)業(ye)(ye)有(you)(you)限(xian)公(gong)司(si)(si)(si)、新疆(jiang)本草堂藥(yao)(yao)業(ye)(ye)有(you)(you)限(xian)公(gong)司(si)(si)(si)等企業(ye)(ye)生產的10批(pi)次淡豆(dou)豉(chi)不(bu)符合規(gui)定,不(bu)符合規(gui)定項目為性狀。
經山(shan)西省食品藥品檢驗所檢驗,標示為普寧市百草(cao)中藥飲(yin)片有限公司(si)、新(xin)疆本草(cao)堂藥業有限公司(si)生產的2批次防風不符合規定,不符合規定項目包(bao)括性狀、含量(liang)測定。
經(jing)青海省藥(yao)(yao)品檢(jian)(jian)驗(yan)檢(jian)(jian)測院(yuan)檢(jian)(jian)驗(yan),標(biao)示為(wei)重慶亞鋒藥(yao)(yao)業(ye)有限(xian)公(gong)司、四(si)川省天府(fu)神龍(long)中藥(yao)(yao)飲(yin)片(pian)有限(xian)公(gong)司、四(si)川五芝中藥(yao)(yao)飲(yin)片(pian)有限(xian)公(gong)司、成都欣福源(yuan)中藥(yao)(yao)飲(yin)片(pian)有限(xian)公(gong)司生(sheng)產的4批次山茱(zhu)萸(yu)(山萸(yu)肉)不符合(he)規定,不符合(he)規定項目包括性(xing)狀、水分(fen)。
經甘(gan)肅省藥(yao)(yao)(yao)品(pin)檢(jian)(jian)驗(yan)研(yan)究院檢(jian)(jian)驗(yan),標(biao)(biao)示為北京(jing)春(chun)風一方制藥(yao)(yao)(yao)有(you)(you)限(xian)(xian)公(gong)司(si)(si)、山東宏濟(ji)堂醫藥(yao)(yao)(yao)有(you)(you)限(xian)(xian)公(gong)司(si)(si)中(zhong)藥(yao)(yao)(yao)廠(chang)、新疆(jiang)本草堂中(zhong)藥(yao)(yao)(yao)飲(yin)片有(you)(you)限(xian)(xian)公(gong)司(si)(si)、安徽亳源藥(yao)(yao)(yao)業(ye)飲(yin)片有(you)(you)限(xian)(xian)公(gong)司(si)(si)生產的4批次血(xue)竭不(bu)符合規(gui)定,不(bu)符合規(gui)定項(xiang)目包括(kuo)鑒(jian)別、醇不(bu)溶物;其中(zhong)標(biao)(biao)示為安徽亳源藥(yao)(yao)(yao)業(ye)飲(yin)片有(you)(you)限(xian)(xian)公(gong)司(si)(si)生產的1批次血(xue)竭同(tong)時檢(jian)(jian)查出808猩紅、松香(xiang)酸(suan)。
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