Taipei: The Taiwan Food and Drug Administration (TFDA) has mandated the recall of two batches of a medication specifically utilized by patients with chronic kidney disease due to identified quality-related issues.
According to Focus Taiwan, the TFDA's directive involves the recall of 1,380,624 tablets of Kremezin 500 mg, identified by batch numbers TT24Y05 and TT24Z13, which are imported by the Taipei-based company Conmed Pharmaceutical and Bio-Medical Corp. The active ingredient in these tablets is spherical absorptive carbon, designed to adsorb toxins and other harmful substances in the gastrointestinal tract of chronic kidney disease patients.
The TFDA disclosed that a report was received from the importer on May 28, following the manufacturer's revelation of deviations in the testing methods for residual ethanol during production. Despite the products meeting specifications and the absence of reported adverse events, a preventive recall was initiated to ensure the continued quality and safety of the medication.
The TFDA has instructed the importer to finalize the recall process and provide an investigation report, along with corrective and preventive measures, by July 1. Non-compliance with this directive could result in fines ranging from NT$200,000 (US$6,326) to NT$5 million, as stipulated by the Pharmaceutical Affairs Act.
The agency clarified that Conmed Pharmaceutical and Bio-Medical Corp. has assured the availability of other unaffected batches, maintaining that there is adequate stock and no threat of a drug shortage.