품질부적합 의약외품 회수 알림 [(주)대일제약_대일드레싱밴드 등 9품목]

품질부적합 의약외품 회수 알림 [(주)대일제약_대일드레싱밴드 등 9품목]󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏 1. 경인지방식품의약품안전청 의료제품안전과-1582호(2016.2.1.), 946호(2016.1.19.), 495호(2016.1.11.), 대구지방식품의약품안전청 의료제품안전과-329호(2016.1.12.), 331호(2016.1.12.), 서울지방식품의약품안전청 의약품안전관리과-1505호(2016.1.29.) 관련입니다.      2. 경인지방식품의약품안전청은 (주)대일제약 ‘대일드레싱밴드’ 등 3품목, 대구지방식품의약품안전청은 태명약업사 ‘뉴태명가아제’ 등 4품목, 서울식품의약품안전청은 ㈜두원사이언스 ‘메딕탄력붕대’ 등 2품목에 대하여 품질부적합의 사유로「약사법」제71조에 의거 판매중지 및 회수, 폐기(그 밖의 위해를 방지할 수 있는 조치 포함) 알림을 요청해온바,      3. 동 사항을 귀 분회 소속 회원들에게 안내하여 주시기 바랍니다.      ○회수 대상 제품<table style="border: 0.28pt solid rgb(0, 0, 0); border-collapse: collapse;"><tbody><tr><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 80.74pt; height: 40.09pt;">업체명</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 83.57pt; height: 40.09pt;">제품명</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 123.19pt; height: 40.09pt;">제조번호(사용기한 및 제조일자)</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 150.74pt; height: 40.09pt;">회수사유</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 40.37pt; height: 40.09pt;">회수등급</td></tr><tr><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 80.74pt; height: 41.17pt;">㈜대일제약</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 83.57pt; height: 41.17pt;">대일드레싱밴드</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 123.19pt; height: 41.17pt;">DDB01010(2018.2.5.)</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 150.74pt; height: 41.17pt;">무균시험 부적합</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 40.37pt; height: 41.17pt;">2</td></tr><tr><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 80.74pt; height: 54.37pt;">한독화장품(주)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 83.57pt; height: 54.37pt;">모생모에스샴푸</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 123.19pt; height: 54.37pt;">HQ14002(2014.3.6.)HQ14004(2014.6.16.)HQ15020(2015.12.8.)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 150.74pt; height: 54.37pt;">HQ14005 품질부적합에 따른 시중 유통 중인 여타 제조번호 자진회수</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 40.37pt; height: 54.37pt;">2</td></tr></tbody></table><table style="border: 0.28pt solid rgb(0, 0, 0); border-collapse: collapse;"><tbody><tr><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 80.74pt; height: 34.43pt;">업체명</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 89.23pt; height: 34.43pt;">제품명</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 117.53pt; height: 34.43pt;">제조번호(사용기한 및 제조일자)</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 150.74pt; height: 34.43pt;">회수사유</td><td valign="center" style="border-width: 0.28pt 0.28pt 1.98pt; border-style: solid solid double; border-color: rgb(0, 0, 0); width: 40.37pt; height: 34.43pt;">회수등급</td></tr><tr><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 80.74pt; height: 164.92pt;">㈜에스테르</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 89.23pt; height: 164.92pt;">보노겐플러스액</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 117.53pt; height: 164.92pt;">D01(2013.01.16.)D02(2013.03.23.)D03(2013.05.16.)D04(2013.09.06.)D05(2013.09.07.)D06(2013.11.04.)D07(2013.11.15.)E01(2014.01.14.)E02(2014.01.14.)E03(2014.03.31.)E04(2014.03.31.)F01(2015.08.26.)</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 150.74pt; height: 164.92pt;">E05 제조번호 품질부적합에 따른 시중 유통 중인 여타 제조번호 자진회수</td><td valign="center" style="border-width: 1.98pt 0.28pt 0.28pt; border-style: double solid solid; border-color: rgb(0, 0, 0); width: 40.37pt; height: 164.92pt;">2</td></tr><tr><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 80.74pt; height: 63.2pt;" rowspan="2">태명약업사</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 89.23pt; height: 31.6pt;">뉴태명가아제</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 117.53pt; height: 31.6pt;">2015-3(2015.03.08.)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 150.74pt; height: 31.6pt;">질량 부적합</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 40.37pt; height: 31.6pt;">3</td></tr><tr><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 89.23pt; height: 31.6pt;">태명가아제3호</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 117.53pt; height: 31.6pt;">2014-11(2014.11.03.)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 150.74pt; height: 31.6pt;">질량 부적합</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 40.37pt; height: 31.6pt;">3</td></tr><tr><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 80.74pt; height: 65.16pt;" rowspan="2">대구위생재료공업사</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 89.23pt; height: 31.6pt;">대구가아제3호</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 117.53pt; height: 31.6pt;">1503(2015.07.01)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 150.74pt; height: 31.6pt;">질량 부적합</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 40.37pt; height: 31.6pt;">3</td></tr><tr><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 89.23pt; height: 33.56pt;">대구멸균거즈3호</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 117.53pt; height: 33.56pt;">M201502F(2015.06.23.)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 150.74pt; height: 33.56pt;">질량 부적합</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 40.37pt; height: 33.56pt;">3</td></tr><tr><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 80.74pt; height: 67.12pt;" rowspan="2">㈜두원사이언스</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 89.23pt; height: 33.56pt;">메딕탄력붕대(10CM×215CM)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 117.53pt; height: 33.56pt;">10140716(2017.7.15.)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 150.74pt; height: 67.12pt;" rowspan="2">중량 및 형상시험 부적합</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 40.37pt; height: 67.12pt;" rowspan="2">2</td></tr><tr><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 89.23pt; height: 33.56pt;">메딕탄력붕대(15CM×215CM)</td><td valign="center" style="border: 0.28pt solid rgb(0, 0, 0); width: 117.53pt; height: 33.56pt;">50211108(2016.11.07.)</td></tr></tbody></table> 붙임: 회수안내문 9부. 끝. <a href='javascript:fileFilterViewer("http://cfile251.uf.daum.net/attach/25232E4B56BD41D61F3D60", "/cfile251/25/232E4B56BD41D61F3D60", "[붙임]품질부적합 의약외품 회수 알림 [(주)대일제약_대일드레싱밴드 등 9품목].pdf", "grpid%3D1Rlm5%26fldid%3DL4Su%26dataid%3D491%26fileid%3D1%26regdt%3D20160212112228&url=http%3A%2F%2Fcfile251.uf.daum.net%2Fattach%2F25232E4B56BD41D61F3D60")'><img src="https://t1.daumcdn.net/daumtop_deco/icon/icon.hanmail.net/editor/p_pdf_s.gif" border="0" alt="첨부파일" class="vam"/> [붙임]품질부적합 의약외품 회수 알림 [(주)대일제약_대일드레싱밴드 등 9품목].pdf</a>