FDA 結果共583筆

Taiwan’s FDA announces a recall of Otsuka America Pharmaceutical’s ABILIFY tablets due to contamination concerns after a notification from the U.S. FDA. The recall affects 1.789 million tablets of 5mg and 30mg doses across three batch numbers, used for treating schizophrenia and other disorders, after unclean production lines led to potential mixing with other pharmaceutical ingredients. The Taiwan FDA urges completion of the recall by May 26 and advises patients to seek alternative treatments.

Explore the ongoing controversy in Taiwan over Kobayashi Pharmaceutical’s red yeast product, as the FDA investigates 58 cases of adverse reactions without confirmed causality, amidst reports of kidney disease and deaths in Japan. Taiwan responds with preventive recalls and consumer protection measures.

人工智慧AI和醫療結合的應用越來越多，肯亞醫療團隊正在開發能準確判讀一般咳嗽和結核病的應用程式，希望能透過縮短患者獲得診斷和治療的時間，降低疾病的傳播。而在美國，正在試驗以「腦深層電刺激」（DBS）治療憂鬱症，這種治療方法透過在大腦植入電極，並在前胸埋置電流裝置，調節大腦區域；由於近期研究成效佳，醫生深信很快會獲得FDA批准使用，讓更多人受惠。

美國「農業部和食藥管理局」（FDA）近日緊急發出公告，宣布將回收國內數批乾洗手液和蘆薈凝膠，主因為這些產品內含可能使消費者出現頭暈、視力模糊或失明等嚴重健康問題的甲醇。

Taipei (TVBS News) reports that Taiwan’s Food and Drug Administration (FDA) has taken action after businesses reported using red yeast rice raw materials from Japan’s Kobayashi Pharmaceutical, linked to kidney disease. Preventive measures have been taken, with products removed from shelves. FDA Director-General Wu Hsiu-mei oversees the situation to safeguard consumer safety.

Kobayashi Pharmaceutical’s red yeast rice health food products have been linked to four deaths in Japan, with over 100 hospitalizations reported. Taiwan’s FDA is urging businesses to report affected products to ensure food safety.

A suspected mass food poisoning incident at a vegetarian restaurant in Taipei’s Xinyi District has left one person dead and eight others ill, according to Taiwan’s Food and Drug Administration. Wu Shou-mei, Director-General of the FDA, stated that three victims are in serious condition. The incident occurred at Polam Kopitiam in the Far Eastern Department Store’s Xinyi A13 branch. Authorities are investigating the cause and testing food samples from the restaurant.

美國政府2024年的「農產品農藥消費者指南」（2024 Shopper’s Guide to Pesticides in Produce）顯示，約有95%比例的非有機草莓、葉菜類（如菠菜和羽衣甘藍）、葡萄、桃子和梨子，都被檢測出有農藥殘留。除此之外，還有像是蘋果、辣椒、櫻桃、藍莓和四季豆等餐桌上常見的蔬果，也都被列入所謂的「12種髒污蔬果」名單中。這個名單從2004年開始發行，每年經過實測調查後，找出12種農藥殘存量最高的常見農產品。

Premier Chen Chien-jen issues a public apology on behalf of the FDA over Sudan Red dye in chili powder. Efforts to address the issue ongoing. Chen pledges to rectify the problem and improve sampling inspection methods.

新冠疫情四年後，美國CDC正式宣布新版防疫指南，比照流感模式，確診者將不需要隔離五天；但醫界強調這不是要逼迫生病的人還得上班，確診初期還是在家休養，也避免傳播。各國敦促施打新冠追加劑，民間反應似乎都不太積極，此時卻傳出德國一名男子為了兜售疫苗證明，竟然在29個月內打了217劑；雖然他沒有確診過，專家仍認為過度接種對防疫力沒有多大幫助。流感疫苗將汰舊更新，美國FDA本周開會決定，今年的流感疫苗將剔除一款山形株B流抗體，因為這款病毒2020年3月後就銷聲匿跡。

現代人因為生活壓力大，不少人長期因頭痛問題，經常失眠感到情緒低落和焦慮。然而，尋求醫生協助，透過身心科藥物，卻又因為副作用，如腸胃不舒服、白天想睡、全身無力等，感到相當不適。現在有一種頭顱微電流刺激(CES)治療法。竟然幫一位年近五十歲的女性患者，治癒長期壓力導致的頭痛精神官能疾患。

Taipei’s FDA suspends chili powder imports from 21 Chinese suppliers for three months due to health concerns. The powder tested positive for Sudan III, a banned substance, prompting a recall of contaminated products. Sudan III is classified as a possibly carcinogenic substance by the WHO. The FDA warns that adding Sudan III to food violates food safety laws and could lead to severe penalties.

日本一架富士夢幻航空（FDA）今（18）日從名古屋機場起飛後突然出狀況，機上跳出警告訊息稱機輪無法收回。機組人員最後決定緊急折返，平安降落原機場，機上65人毫髮無傷。

Taiwan’s FDA confirms detection of Cimbuterol in pork sample from Taichung, with trace levels at 0.001ppm. Public urged not to worry as only one package tested positive and levels are very low. Further test results to be released after the holiday.

Taiwan’s Food and Drug Administration (FDA) has confirmed that no traces of the drug Cimbuterol were found in TaiSugar’s frozen pork slice products. The Taichung City Government previously reported the presence of 0.002ppm of Cimbuterol in pork cuts manufactured by TaiSugar. However, the Ministry of Agriculture disputed this claim, stating that tests on both pig hair from the farm of origin and samples from the same batch of pork products were negative for beta-agonists. Wang Der-yuan, the FDA deputy director, emphasized that Cimbuterol is not approved for use in humans or animals and is primarily used as a standard sample in laboratories. The FDA conducted examinations of three samples of TaiSugar’s pork products using the Ministry of Health and Welfare’s protocol for testing veterinary drug residues, and the results showed no traces of Cimbuterol.

A shipment of strawberries from Saitama, Japan has been found to have excessive pesticide residue, according to Taiwan’s Food and Drug Administration (FDA). The imported strawberries, weighing a total of 3.5 kilograms, exceeded permitted pesticide levels. Deputy Director of the FDA, Lin Chin-fu, stated that all imported Japanese strawberries undergo 100% customs inspection. From July 15, 2023 to January 15, 2024, 2.3 metric tons of Japanese strawberries were discovered to contain pesticide residue. Out of 325 batches inspected, 14 failed the inspection, resulting in a failure rate of 4.31%. Since June 1, 2023, all shipments of strawberries from Japan to Taiwan have been subjected to batch-by-batch inspections. Japanese manufacturers failing inspections will face a one-month import suspension.

根據美強生營養品公司（Mead Johnson Nutrition, 簡稱MJN）自主公告，該公司已在美國召回部分安敏捷低敏奶粉產品。這項召回行動的原因是，產品在美國以外地區，可能受到阪崎腸桿菌（Cronobacter sakazakii）的污染。

Taiwan’s Food and Drug Administration (FDA) has identified two batches of Japanese strawberries as non-compliant due to pesticide residue issues. The strawberries, imported from Fukuoka and Tochigi, failed to pass border inspections and will now undergo 100 percent batch inspection. Out of the 1,084 batches of Japanese strawberries inspected this year, 19 were found to be non-compliant, accounting for a rate of 1.75 percent. The FDA will continue to conduct thorough inspections until April 30, 2024, to ensure compliance with pesticide residue regulations.

由藥廠諾和諾德（Novo Nordisk）研發、本用來調節胰島素的藥物胰妥讚（Ozempic），因為能減重的副作用讓這款藥物一舉爆紅，一上市就引起討論。但《路透》報導，美國食品藥物管理局（FDA）日前卻查獲，數千支偽造版的減肥針產品，利用相似外包裝魚目混珠，讓消費者難以辨別真偽。FDA在聲明中提醒，不要從非官方或陌生通路購買藥物，因為冒牌藥物無論在成份或使用的針頭都來源不明，一旦使用很可能引發後遺症，目前雖已沒收數千支偽造藥品，但市面上可能還有偽造藥物在流通。

美國食品藥物管理局（FDA）宣布回收美國桂格燕麥公司旗下疑遭沙門氏菌汙染的部分產品。食藥署今天表示，經查台灣近2年沒有輸入相關產品，但將展開同公司其他在台產品稽查。

The Food and Drug Administration (FDA) announced that two kilograms of green tea powder imported from Japan were destroyed at the border due to trace amounts of radioactive cesium-137. The batch’s cesium-137 levels were within the acceptable limit of 100 becquerels per kilogram, but the FDA emphasized the importance of ethical practices and urged businesses to adhere to them. The FDA tested the batch on October 31 and found 3 becquerels per kg of cesium-137 and 3 becquerels per kg of cesium-134 plus cesium-137. Since last year, food from five prefectures of Fukushima, Japan, has been imported to Taiwan, provided it meets radiation and origin inspection requirements. The FDA’s regulations for cesium-134 and cesium-137 levels in various food categories are based on the ＂Standards for the Tolerance of Atomic Dust and Radioactivity Contamination in Foods.＂ From 2011 to 2023, Taiwan has tested 224,970 batches of Japanese food, with 252 samples showing trace radioactivity that did not exceed national or Japanese standards.

美國14州有22名幼童鉛中毒，出現噁心、嘔吐和腹瀉等症狀。美國衛生官員指出，這些幼兒食用的蘋果醬和肉桂蘋果泥，檢驗後含鉛量極高，美國食品藥物管理局（FDA）緊急宣布緊急召回3款商品。

美國食品與藥物管理局（FDA）上個月30日下令召回26款眼藥水，並稱這批藥水在生產過程「存在被細菌感染」的風險，而詳細原因近日曝光：這些眼藥水是在印度1家不衛生的工廠生產，據稱工人們在工廠內「赤腳」、甚至以假衛生檢測報告來讓產品看似安全，最終更掛著知名連鎖藥妝CVS Health、連鎖賣場Target以及沃爾瑪（Walmart）等廠牌進到市面販售。

美國食品與藥物管理局（FDA）30日再次下令，一口氣召回26款眼藥水，因為這批藥水在生產過程，存在被細菌感染的風險，其生產線衛生條件不合格，很可能造成民眾眼部感染，甚至傷害視力或導致更嚴重病變。從美媒報導中能看到，被召回的眼藥水包含6個廠牌，像是知名連鎖藥妝CVS、連鎖賣場Target等，目前半數產品已經從實體通路下架，但仍有不少眼藥水，依然能在電商平台購買。

天氣轉涼，讓各種病毒伺機而動；美國CDC疾管中心預測，今年國內呼吸道傳染病疫情，將和去年秋冬一樣糟，甚至可能超越大流行前的情況。然而就在這個時候，卻傳出能為新生兒施打、對抗RSV病毒的重要工具供應有限，評估應為高風險嬰兒優先施打，這代表健康的寶寶可能失去獲得保護的機會。另外，FDA最新公布的研究指出，流感和新冠疫苗同時施打，可能讓年長者中風的風險升高。