The Food and Drug Administration (FDA) yesterday announced the recall of three types of drugs over excessive impurities or failing a dissolution test, including a diabetes drug with a 100 percent share of the local market.
The three types of drugs are three batches of 100mg Januvia F.C. tablets (佳糖維100毫克膜衣錠), a batch of 30mg Lexinping capsules “Tai Yu” (台裕樂心平膠囊30毫克) and a batch of 10mg Sermion tablets (適脈旺糖衣錠10毫克).
The Januvia film-coated tablets, the main ingredient of which is sitagliptin (as monohydrate phosphate salt), is prescribed to adults with type 2 diabetes to improve blood sugar control.
Photo copied by Wu Liang-yi, Taipei Times
Its drug permit holder, Merck Group Taiwan, had notified the FDA about finding excessive levels of impurities.
The three batches — U011910, U015917 and U018641 — would be recalled by Jan. 21, the FDA said.
Although the drug has a 100 percent market share, with more than 27 million tablets used annually, only about 1.2 million tablets are being recalled, said Hung Kuo-teng (洪國登), head of the FDA’s Medicinal Products Division.
There are other drugs with different ingredients that diabetes patients can use as replacement, Huang added.
Lexinping is mainly used to treat depression. The manufacturer decided to recall batch WE1304, comprising about 16,000 capsules, after samples taken from the batch were found to have a dissolution rate that failed to meet the specifications, which could affect the efficacy of the drug.
Hung said Lexinping capsules have only about a 3 percent market share, with about 820,000 capsules used per year, so there should not be a shortage of medication due to the recall, adding that the recall would run through Jan. 14.
Sermion tablets are mainly used to improve peripheral blood circulation. Its manufacturer, Viatris Pharmaceutical, detected impurities that failed to meet the specifications while conducting a stability test, and is recalling batch DN2443, which comprises about 2.7 million tablets.
Hung said that about 6.3 million Sermion tablets are used in the nation per year, translating into a market share of about 60 percent, but as there are alternative drugs, the recall would not cause a shortage of medication for patients.
Additional reporting by CNA
Chinese Nationalist Party (KMT) Chairman Eric Chu (朱立倫), spokeswoman Yang Chih-yu (楊智伃) and Legislator Hsieh Lung-chieh (謝龍介) would be summoned by police for questioning for leading an illegal assembly on Thursday evening last week, Minister of the Interior Liu Shyh-fang (劉世芳) said today. The three KMT officials led an assembly outside the Taipei City Prosecutors’ Office, a restricted area where public assembly is not allowed, protesting the questioning of several KMT staff and searches of KMT headquarters and offices in a recall petition forgery case. Chu, Yang and Hsieh are all suspected of contravening the Assembly and Parade Act (集會遊行法) by holding
PRAISE: Japanese visitor Takashi Kubota said the Taiwanese temple architecture images showcased in the AI Art Gallery were the most impressive displays he saw Taiwan does not have an official pavilion at the World Expo in Osaka, Japan, because of its diplomatic predicament, but the government-backed Tech World pavilion is drawing interest with its unique recreations of works by Taiwanese artists. The pavilion features an artificial intelligence (AI)-based art gallery showcasing works of famous Taiwanese artists from the Japanese colonial period using innovative technologies. Among its main simulated displays are Eastern gouache paintings by Chen Chin (陳進), Lin Yu-shan (林玉山) and Kuo Hsueh-hu (郭雪湖), who were the three young Taiwanese painters selected for the East Asian Painting exhibition in 1927. Gouache is a water-based
Taiwan would welcome the return of Honduras as a diplomatic ally if its next president decides to make such a move, Minister of Foreign Affairs Lin Chia-lung (林佳龍) said yesterday. “Of course, we would welcome Honduras if they want to restore diplomatic ties with Taiwan after their elections,” Lin said at a meeting of the legislature’s Foreign Affairs and National Defense Committee, when asked to comment on statements made by two of the three Honduran presidential candidates during the presidential campaign in the Central American country. Taiwan is paying close attention to the region as a whole in the wake of a
OFF-TARGET: More than 30,000 participants were expected to take part in the Games next month, but only 6,550 foreign and 19,400 Taiwanese athletes have registered Taipei city councilors yesterday blasted the organizers of next month’s World Masters Games over sudden timetable and venue changes, which they said have caused thousands of participants to back out of the international sporting event, among other organizational issues. They also cited visa delays and political interference by China as reasons many foreign athletes are requesting refunds for the event, to be held from May 17 to 30. Jointly organized by the Taipei and New Taipei City governments, the games have been rocked by numerous controversies since preparations began in 2020. Taipei City Councilor Lin Yen-feng (林延鳳) said yesterday that new measures by
RSS