1. data.fda.gov.tw
  2. 消費紅綠燈-國際食品資料集
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燈號 綠燈
標題名稱 美國食品藥物管理局(FDA)發布Doctor’s Best公司自主回收含有未批准成分lovastatin之紅麴米膳食補充劑600毫克膠囊產品(Red Yeast Rice dietary supplement,600 mg Capsules)，問題產品無向本署申請輸入查驗紀錄。
內容 <ol> <li><span style="color: #000000;"><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">美國食品藥物管理局(FDA)於103年6月24日發布Doctor&rsquo;s Best公司自主回收含有未批准成分lovastatin之</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">紅麴</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">米膳食補充劑</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">600</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">毫克</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">膠囊</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">產品(Red Yeast Rice dietary supplement, 600 mg Capsules)共7379瓶。</span> </span></li> <li><span style="font-size: 14pt; font-family: 標楷體; color: #000000; line-height: 150%;">問題產品已銷往美國所有地區零售通路銷售。 </span></li> <li><span style="font-size: 14pt; font-family: 標楷體; color: #000000; line-height: 150%;">問題產品之詳細資訊如下： </span></li></ol><table width="479" style="border-collapse: collapse; margin: auto auto auto 18pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 89.75pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000; line-height: 150%;">品名 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 49.6pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000; line-height: 150%;">數量/容量 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 63.8pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000; line-height: 150%;">有效日期 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 77.95pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000; line-height: 150%;">批號 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 78pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="color: #000000;"><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">UPC</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">碼 </span></span></p> </td> </tr> <tr style="height: 62.35pt;"> <td valign="top" style="border-top: #f0f0f0; height: 62.35pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 89.75pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000; line-height: 150%;">Red Yeast Rice dietary supplement, 600 mg Capsules</span></p> </td> <td valign="top" style="border-top: #f0f0f0; height: 62.35pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 49.6pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="color: #000000;"><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">120</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">粒/瓶 </span></span></p> </td> <td valign="top" style="border-top: #f0f0f0; height: 62.35pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 63.8pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="color: #000000;"><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">2017</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">年2月</span> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; height: 62.35pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 77.95pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="font-family: arial, sans-serif; color: #222222;">3121005 </span></p> </td> <td valign="top" style="border-top: #f0f0f0; height: 62.35pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 78pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; line-height: 150%;"><span style="font-family: arial, sans-serif; color: #000000;">753950001183</span></p> </td> </tr> </tbody></table><p><span style="color: #000000;"></span></p><p><span style="color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">&nbsp;&nbsp;4.目前尚無相關病例回報，</span><span style="font-size: 14pt; font-family: 標楷體;">問題產品未輸入我國，本案經評估列屬綠燈。</span> </span></p><p><span style="color: #000000;"><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">&nbsp; 5.該國發布原警訊連結如下</span><span style="font-size: 14pt; line-height: 150%;">:</span></span></p><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">http://www.fda.gov/Safety/Recalls/ucm402584.htm</span>;;<ol> <li><span style="color: #000000;"><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">食品藥物管理</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">署</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">呼籲民眾如赴</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">美國</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">旅遊，應注意相關回收警訊，</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">避免購買及食用問題食品。</span> </span></li> <li><span style="color: #000000;"><span style="font-size: 14pt; font-family: times new roman, serif;">lovastatin</span><span style="font-size: 14pt; font-family: 標楷體;">可能會導致嚴重的肌肉損傷，該成分亦可能對孕婦產生風險，或造成肝臟疾病患者在長期使用下增加肝臟損害。</span></span></li></ol>;;<p style="line-height: 150%; 29: ;"><span style="color: #000000;"><span style="font-size: 14pt; line-height: 150%;">1.<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">案內產品現查</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">無向本署申請輸入查驗紀錄</span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">，業者應避免輸入原廠回收產品。</span> </span></p><p style="line-height: 150%; 29: ;"><span style="color: #000000;"><span style="font-size: 14pt; line-height: 150%;">2.<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; line-height: 150%;">若有輸入類似或疑似回收警訊產品或相關產品，應立即向外國原廠或出口廠商查證，並依自主管理原則，主動暫停已進口之疑似回收產品販售。</span> <br /><br /><span style="font-size: 18px;">3.</span><span style="font-size: 14pt; font-family: 標楷體;">若獲原廠通知已進口之產品為需回收產品，應立即主動下架回收，通知消費者退換貨，並通知公司所在地衛生局與本署。</span></span></p>
更新日期 2014-06-30
附檔 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=5820&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=5821&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=5822&type=0