Sinphar Pharmaceutical Co Ltd (杏輝) yesterday apologized to the public for quality problems in 23 kinds of drugs, saying that it plans to recall all of them within the next two months.
The recall is expected to result in revenue losses of NT$28 million (US$966,684), accounting for 2.32 percent of its revenue in the first half of this year, Sinphar said in a filing with the Taiwan Stock Exchange.
The company said that it expected to be fined NT$30,000 to NT$2 million.
Photo: Chen Yung-chi, Taipei Times
Sinphar last week examined all of its 288 drug lines after the Food and Drug Administration (FDA) found in a regular examination in July that six of its drugs had quality issues.
In stability tests, which show how the quality of a drug varies over time under the influence of environmental factors, the six were found to have less than 90 percent of their labeled potency, which meant they failed the tests, the administration’s data showed.
The agency demanded that Sinphar stop selling the six and recall them, to safeguard the interests of consumers.
“As the event has harmed our reputation, we decided to run a comprehensive inspection on all of our products to find out whether other products had the same quality issues,” Sinphar spokesperson Amy Lou (樓怡美) said.
The company found that another 17 drugs had less than 90 percent of their labeled potency and would recall them, Lou said.
The reduction of the drugs’ potency could be attributed to the manner in which they are packaged, as the firm packaged some of its ointments in plastic bottles instead of aluminum tubes, making it easier for the chemicals to evaporate, she said.
Meanwhile, some drugs’ potency weakens due to improper storage methods, the firm said.
For example, it recommends that its ointment for hemorrhoids be stored at room temperature, which can accelerate the chemical reaction between different ingredients, the company said, adding that it is considering changing the ointment’s label and asking users to store the product in the refrigerator.
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