TFDA orders recall of over 87,000 antihypertensive tablets

Taipei, Aug. 12 (CNA) The Taiwan Food and Drug Administration (TFDA) has ordered the recall of 87,360 tablets of the antihypertensive drug Beniel F.C. Tablets 8 mg manufactured by Synmosa Biopharma Corp. over concerns that the medication may not work as intended, the agency said Wednesday.

Speaking to reporters, TFDA official Liu Chia-ping (劉佳萍) said the recall was initiated after Synmosa notified the agency that a recent stability test found the tablets failed to meet the required dissolution standards, which could affect the drug's quality and effectiveness.

The TFDA said the recall applies to batch No. 2KA31 of Beniel F.C. Tablets 8 mg, which is registered under license No. 057368.

According to the agency, the drug contains benidipine hydrochloride as its active ingredient and is used to treat high blood pressure.

The TFDA said the recall must be completed by Aug. 24. Synmosa has also been required to submit an investigation report and details of a corrective action plan for future production by that date.

Under the Pharmaceutical Affairs Act, companies that fail to comply with the recall order face fines ranging from NT$200,000 (US$6,209) to NT$5 million, the TFDA said.

Citing Synmosa, Liu said other batches of Beniel F.C. Tablets 8 mg are not affected and the company has sufficient inventory. Production will continue, so there are no concerns about a shortage, she said.

Liu advised patients with concerns to consult their physicians about alternative prescriptions if necessary.