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
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