The Food and Drug Administration (FDA) yesterday ordered a recall of a batch of hypertension drug, consisting of 87,360 tablets.
The FDA said it received notification of a defective drug product — Beniel F.C. Tablets 8mg, batch code 2KA31 — manufactured by Synmosa Biopharma Corp. The batch was registered with the Department of Health as Pharmaceutical Manufacture No. 057358.
The drug’s active ingredient is benidipine hydrochloride, a long-acting calcium channel blocker used to treat high blood pressure by relaxing blood vessels to improve blood flow.
Photo: Lin Chih-yi, Taipei Times
FDA Division of Medicinal Products senior technical specialist Liu Chia-ping (劉佳萍) said that the manufacturer initiated the recall because the tablets did not pass a dissolution test measuring their stability, meaning the quality and effectiveness of the drug might have been compromised.
The manufacturer has been ordered to complete the recall before Aug. 24, as well as submit an investigation report, and a corrective and preventive action report, the FDA said.
Article 91 of the Pharmaceutical Affairs Act (藥事法) stipulates that companies that fail to comply with a recall order are to be fined NT$200,000 to NT$5 million (US$6,202 to US$155,058), it said.
Synmosa has two licenses for producing drugs with the same active ingredient, Liu said.
Other batches produced by Synmosa using the ingredient were not affected and the firm has sufficient inventory to ensure there would not be a shortage, she said.
The FDA urged hospitals and pharmacies to comply with the recall, and said people taking the drug should consult their doctor if they want to change their prescription.
Separately, the Centers for Disease Control (CDC) on Tuesday said that a misdiagnosis resulted in the erroneous reporting of the first domestic case of typhoid fever this year.
The centers on Thursday last week reported that a woman in her 70s in central Taiwan was hospitalized last month with a persistent fever and diarrhea, and returned home after treatment.
An accredited laboratory at a hospital reported that it had detected Salmonella typhi, the bacteria that causes typhoid fever, in the woman’s blood, the centers said.
However, full-genome sequencing by a CDC laboratory showed that the bacterial strain was actually non-typhoidal salmonella, CDC Deputy Director-General Lin Ming-cheng (林明誠) said.
The hospital laboratory was ordered to correct its report as stipulated in the Quality Assurance Operational Requirements for Communicable Disease Diagnostic Laboratories and the typhoid case report was officially retracted on Monday, Lin said.
The CDC said it instructed accredited typhoid fever testing laboratories to strictly implement a “dual-person verification” mechanism for positive serum agglutination results and to release results only after confirming that laboratory data is accurate.
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