TAIPEI (Taiwan News) — Taiwan’s Food and Drug Administration has ordered the recall of a batch of Beniel F C Tablets 8 mg, a prescription medication for high blood pressure, after testing raised concerns about its effectiveness.
The affected batch, numbered 2KA31, failed to meet dissolution standards during stability testing. A total of 87,360 tablets have been distributed, according to CTEE.
The FDA was notified by Synmosa Biopharma Corp., the holder of the drug’s marketing authorization. The company has been instructed to complete the recall by Aug. 24 and submit an investigation report and preventive action plan.
Failure to carry out the recall as required could result in a fine of NT$200,000 (US$6,207) to NT$5 million under Article 91 of the Pharmaceutical Affairs Act.
The FDA said there are no concerns about a shortage, as other batches remain available and production will continue. Two other products containing the same active ingredient are also authorized for sale.
The affected tablets contain benidipine hydrochloride, which is primarily used to treat high blood pressure. It works by widening blood vessels, lowering blood pressure and making it easier for the heart to pump blood, according to Synapse.
The FDA advised patients with concerns about their medication to return to their doctors as soon as possible.
