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
NATIONAL SECURITY: Authorities are working to confirm the identities of the military personnel involved and investigating possible illegal conduct and regulatory violations Authorities are probing possible national security implications after Kinmen police and immigration officers on Sunday found a Chinese woman allegedly posing as a tourist while engaging in prostitution involving more than 10 military personnel. The woman, surnamed Chen (陳), has since been deported, authorities said, adding that investigators are still working to confirm the identities of those implicated, as the records only listed code names and aliases. The case stemmed from a report received by the Kinmen District Prosecutors’ Office on Friday last week from the Jinhu Precinct of the Kinmen County Police Bureau. On Sunday, police, along with the National Immigration
GLOBALGIVING: ‘ Caving to external pressure is not acceptable for an organization that has cultivated justice reform and human rights for 30 years,’ one NGO said A slew of non-government organizations (NGOs) have withdrawn from the GlobalGiving fundraising platform after it announced it would use “Chinese Taipei” instead of “Taiwan” from next month. The Taiwan Good Rice Association wrote on Facebook on Friday that it was informed on April 28 via a teleconference call of the change, which was made because the platform wanted to operate in China. Taiwan Good Rice is to terminate all cooperative relationships with GlobalGiving in response to the platform’s “unilateral and non-negotiable” decision to remove references to Taiwan, the NGO said. “Taiwan is in the official name of Taiwan Good Rice Association and the
HEAVY WEATHER: Typhoon Jangmi is due to crash straight into the Ryukyus as airlines look to shift flights to larger aircraft or cancel flights to Okinawa entirely Taiwan’s international air carriers announced flight adjustments over the weekend as Typhoon Jangmi is forecast to hit the Ryukyu Islands today and tomorrow. The Central Weather Administration (CWA) upgraded Jangmi from a tropical storm to a typhoon at 8am yesterday, with the eye located 580km south of Naha city. It was moving north at 19kph. Today, China Airlines’ CI-120, CI-121, CI-122 and CI-123 flights between Taoyuan and Naha, Okinawa, have been canceled as well as CI-132 and CI-133 between Kaohsiung and Naha. EVA Air’s BR-112, BR-113, BR-186 and BR-185 flights between Taoyuan and Naha are also canceled. Low-cost carrier Tigerair Taiwan canceled IT-230,
MULTIPRONGED APPROACH: China has sought to pressure Palau across a number of fronts, but the island nation has staunchly resisted overtures to ditch Taiwan Palau has been firm in backing Taiwan despite Chinese pressure that uses tourism economics, cyberattacks and criminal infiltration as tools to threaten the Pacific ally into renouncing its recognition of Taiwan as a sovereign state. The Presidential Office yesterday announced that Vice President Hsiao Bi-khim (蕭美琴) would visit Palau from Saturday to Wednesday next week at the invitation of Palauan President Surangel Whipps Jr. Whipps in April said in an interview that China had outspokenly asked Palau to “denounce Taiwan.” “And we have said: ‘We have no enemies, but nobody tells us who our friends are,’” he said. Whipps has told reporters multiple times
RSS