03/06/2011 'Super-C chewable tablets' was one of five pharmaceutical products recalled yesterday by local authorities The local health authority has recalled five more drugs allegedly tainted with a toxic plasticiser manufactured in Taiwan. According to a press statement released by the Health Bureau (SSM) yesterday, the Hong Kong health authorities found plasticiser DEHP in 'Well Tab' a medicine for stomach discomfort manufactured by China Chemical & Pharmaceutical and Pharm Company Limited, Taiwan. The product was found to contain DEHP at a level of 1.2 ppm (parts per million). According to the Hong Kong Department of Health, the level of DEHP is considered unlikely to cause acute harmful effects if taken according to the recommended dosage. Apart from recalling 'Well Tab', the Hong Kong authority also endorsed the voluntary recall of four pharmaceutical products manufactured by Marching Pharmaceutical Limited even though no plasticiser was found. However, the sample of flavouring agent contained DEHP at a level of 1.1 ppm. Although no DEHP was found in the products, the manufacturer offered to conduct a voluntary recall of all of them. The products are for Vitamin C supplement and dietary supplement for joints and cartilage respectively. These products – 'Cebio Chewable Tablet', 'Cevizo Vitamin C chewable tablets', 'Super-C chewable tablets' and 'Arthritil Powder for Oral Solution' – and 'Well Tab' have all been imported into Macau. The SSM has asked local pharmacies, drug stores and distributors to remove these products from the market. The health authority has also called on the public not to use these drugs, if they have purchased them. On Tuesday an anti-gastric acid drug in syrup form, 'Scrat Suspension Standard', was also recalled after examinations discovered DIBP, one of the 16 types of plasticisers that should not be used in food. Plasticisers such as DEHP and DIBP could cause hormonal disturbance and affect the male reproductive system if overused and consumed for a long time.The SSM director, Lei Chin Ion, stressed that plasticisers will largely be excreted within 24 hours after ingestion, calling on the public to "drink more water" if they suspect that they have consumed this toxic chemical. Meanwhile, the results of random tests conducted on Macau's Taiwanese-style food and beverage retail shops should be released today. On Monday, deputy director of the Economic Services Bureau Tai Kin Ip said random tests had already begun in Macau's Taiwanese-style food and beverage retail shops.The Consumer Council has also requested all the Taiwanese-style beverage stores under its certified shop program to submit proofs of the source of raw materials. Taiwanese authorities have arrested the owner of a company that used DEHP rather than more expensive palm oil in products supplied to dozens of local drink makers. He faces up to six months in jail.
Thursday, June 2, 2011
塑化劑鄰苯二甲酸酯約有20多項，常用為DHEP等6項
食品安全(起雲劑含塑化劑)跨部會專案會議(第六次) (TFDA發布日期2011-06-02)全國掃除塑化劑污染食品稽查行動：一、全國稽查首日行動，至6月2日12時止，已出勤人數1,478人次，稽查6,219家數，接受衛生局查處之製造商: 18,123品項，限時改正：738家。二、檢驗項目及能量：民間實驗室：24家（新增3家），檢驗量能計2,080件/日，輔導中15家（預估檢驗量能計630件/日）；檢測時，用全頻質譜掃描，偵測所有鄰苯二甲酸酯類訊號。雖然，鄰苯二甲酸酯類塑化劑品項約有20多項，常用為DHEP等6項，歐盟及我國經濟部標檢局對於玩具安全皆檢驗這6種塑化劑。因此，目前會先以這6種塑化劑的標準品作定量檢測，但如檢驗時偵測到有異常之訊號，則再以推斷的其他類標準品加以確認及定量。三、全國稽查行動假日不停歇，各地衛生單位人員、消保官於端午節期間，將會加強稽查各觀光、遊樂區週邊的食品通路、販售點，確保民眾食的安全。四、對於上架之產品加強稽查抽驗，至6月2日8時止，各地衛生局已抽樣送驗112件，目前完成4件，均未篩檢出塑化劑。五、對於生達公司、中化公司生產之胃乳產品可能塑化劑，已全面下架、停止販售使用，衛生單位將持續追查其產品原料來源。各部會重要辦理事項：一、經濟部：國貿局將公告增訂五大類食品之輸出規定，業者應檢附行政院衛生署或其指定檢驗機關(構)核發之合格證明文件，始得出口，確保台灣優良產品信譽。二、衛生署：(一)完成食品衛生管理法修法草案，於今日(6/2)行政院會已通過，送立法院審議。修改該法第31條，對於違規者可處罰行政罰鍰6萬至600萬元，修改第34條，對於違法並致危害人體健康者可處5年以下有期徒刑、拘役或科或併科1,000萬元以下罰金。(二)全國已有119家醫院開設健康諮詢門診，至6月2日12時為止，累計已提供諮詢服務計926人次(署立醫院603人次)，其中轉介至專科門診進一步檢視的有23人次。(三)持續製作塑化劑對人體影響之QA衛教資料，主動提供民眾參考；今日將再次邀集各相關醫學會、國衛院等專家學者召開專家會議。三、環保署：(一)昨日(6/1)已召開毒性化學物質管理專家審議小組會議，建議常用的8種塑化劑改列為第一類或第一、二類，其他鄰苯二甲酸酯類塑化劑亦採預防性措施，皆改列為第四類管理，將會進行預告、公聽研商等程序。(二)為避免造成二度污染，衛生署、環保署密切配合，嚴密監督並公開銷毀受塑化劑污染之產品。
生達有苦難言，無端扯入塑化劑風暴!
食品藥物管理局對生達公司保胃懸乳測出DIBP（diisobutyl phthalate）的說明及處理 (TFDA發布日期2011-06-02)澳門衛生局檢驗我國生達化學製藥公司「保胃懸乳液 " 生達 " （ scrat suspension "standard" ）」產品，測出 DIBP（ diisobutyl phthalate ） 鄰苯二甲酸二 異丁酯 的物質乙事，食品藥物管理局相關措施及說明如下：一、 生達化學製藥公司「保胃懸乳液 "生達 "（ scrat suspension "standard"）」，為衛生署核准之處方藥品，許可證字號「 衛署藥製字第 043945 號」，適應症為「胃潰瘍 、十二指腸潰瘍、食道潰瘍、逆流性食道炎 」。二、 該藥品的原料共有 12 項，除其中一項原料 95 ％酒精是來自台灣，其他原料來自進口。原料來源非為昱伸、賓漢及其下游廠商。三、 該藥品經實驗室檢驗結果，未篩檢出含有 6 項塑化劑物質（ BBP ， DBP ， DEHP ， DNOP ， DINP ， DIDP ）。四、 由於塑膠容器或材質為增加延展性常會加入塑化劑，為合法的商品原料，有時遇熱會游離至產品，所以產品有 不表示是非法加入，必須加以調查釐清來源。因此，食品藥物管理局已緊急對該藥品的原料及成品詳加追查。五、 DIBP （ diisobutyl phthalate ） 鄰苯二甲酸二異丁酯 ， 係與 DBP ( Dibutyl Phthalate ) 相似的塑化劑成分， 經查目前世界各國尚未對 DIBP 進行管制，在台灣亦非屬環保署公告的管制毒 性化學物質。六、 為保護民眾用藥安全， 生達公司已暫時停止該藥品相關原料及產品的出貨，同時自主性將該藥品自藥局 、 藥商等通路全面下架，等待追查結果。七、食品藥物管理局將會積極與澳門相關單位進行了解。為確保藥物安全與醫療效能，衛生署已建置藥物安全監測機制，即時監視國內、外藥物安全訊息，除設有藥物不良反應通報系統及藥物不良品通報中心之外，並對於藥物之安全性與療效亦隨時進行再評估，如醫療人員或病患疑似因使用（服用）藥品導致不良反應之發生，請立即通報衛生署所建置之全國藥物不良反應通報中心，藥物不良反應通報專線 02-2396-0100 ，網站：http://adr.doh.gov.tw 。 如發現藥物不良品時，請立即通報衛生署所建置之全國藥物不良品通報中心，藥物不良品通報專線 02-2396-0100 ，網站： http://recall.doh.gov.tw 。
Posts
