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
Taiwan yesterday condemned the recent increase in Chinese coast guard-escorted fishing vessels operating illegally in waters around the Pratas Islands (Dongsha Islands, 東沙群島) in the South China Sea. Unusually large groupings of Chinese fishing vessels began to appear around the islands on Feb. 15, when at least six motherships and 29 smaller boats were sighted, the Coast Guard Administration (CGA) said in a news release. While CGA vessels were dispatched to expel the Chinese boats, Chinese coast guard ships trespassed into Taiwan’s restricted waters and unsuccessfully attempted to interfere, the CGA said. Due to the provocation, the CGA initiated an operation to increase
A crowd of over 200 people gathered outside the Taipei District Court as two sisters indicted for abusing a 1-year-old boy to death attended a preliminary hearing in the case yesterday afternoon. The crowd held up signs and chanted slogans calling for aggravated penalties in child abuse cases and asking for no bail and “capital punishment.” They also held white flowers in memory of the boy, nicknamed Kai Kai (剴剴), who was allegedly tortured to death by the sisters in December 2023. The boy died four months after being placed in full-time foster care with the
A Taiwanese woman on Sunday was injured by a small piece of masonry that fell from the dome of St Peter’s Basilica in the Vatican during a visit to the church. The tourist, identified as Hsu Yun-chen (許芸禎), was struck on the forehead while she and her tour group were near Michelangelo’s sculpture Pieta. Hsu was rushed to a hospital, the group’s guide to the church, Fu Jing, said yesterday. Hsu was found not to have serious injuries and was able to continue her tour as scheduled, Fu added. Mathew Lee (李世明), Taiwan’s recently retired ambassador to the Holy See, said he met
The Shanlan Express (山嵐號), or “Mountain Mist Express,” is scheduled to launch on April 19 as part of the centennial celebration of the inauguration of the Taitung Line. The tourism express train was renovated from the Taiwan Railway Corp’s EMU500 commuter trains. It has four carriages and a seating capacity of 60 passengers. Lion Travel is arranging railway tours for the express service. Several news outlets were invited to experience the pilot tour on the new express train service, which is to operate between Hualien Railway Station and Chihshang (池上) Railway Station in Taitung County. It would also be the first tourism service
RSS