Over 1.3 million kidney disease tablets recalled over quality issues

Taipei, June 13 (CNA) The Taiwan Food and Drug Administration (TFDA) has ordered the recall of two batches of a medication used by chronic kidney disease patients due to quality-related issues.

According to information released by the TFDA earlier this week, the recall covers 1,380,624 tablets of Kremezin 500 mg (batch numbers TT24Y05 and TT24Z13), imported by Taipei-based Conmed Pharmaceutical & Bio-Medical Corp.

It contains spherical absorptive carbon as its active ingredient and is designed to adsorb toxins and other harmful substances in the gastrointestinal tract of patients with chronic kidney disease.

The TFDA said it received a report from the importer on May 28 after the manufacturer reported deviations in testing methods for residual ethanol during production.

According to the report, although the products met specifications and no adverse events were reported, a preventive recall was launched to ensure drug quality and safety.

The TFDA said it has required the importer to complete the recall and submit an investigation report and corrective and preventive measures by July 1. Failure to comply will result in a fine from NT$200,000 (US$6,326) to NT$5 million under the Pharmaceutical Affairs Act.

The agency said the Taipei company has reported that other unaffected batches remain available, with sufficient stock on hand, and that there is no risk of a drug shortage.