Taipei: The Taiwan Food and Drug Administration (TFDA) has mandated the recall of 87,360 tablets of the antihypertensive drug Beniel F.C. Tablets 8 mg, manufactured by Synmosa Biopharma Corp., due to concerns about the drug's effectiveness. This recall decision follows findings that the tablets may not perform as intended.

According to Focus Taiwan, the recall was prompted after Synmosa informed the TFDA that a recent stability test revealed the tablets did not meet the necessary dissolution standards, potentially impacting their quality and efficacy. The recall specifically targets batch No. 2KA31 of the Beniel F.C. Tablets 8 mg, which holds the registration license No. 057368.

The TFDA has indicated that the active ingredient in this antihypertensive medication is benidipine hydrochloride, utilized primarily for the management of high blood pressure. The recall process is expected to be concluded by August 24, with Synmosa required to submit an investigation report and a corrective action plan regarding future production by the same date.

Under the Pharmaceutical Affairs Act, non-compliance with the recall order could result in fines ranging from NT$200,000 (US$6,209) to NT$5 million. Synmosa has reassured, as cited by Liu Chia-ping, a TFDA official, that other batches of the medication remain unaffected and that there is adequate inventory available. Production will continue, ensuring no anticipated shortages.

Patients concerned about their prescriptions are advised to consult their healthcare providers for possible alternatives.