Recall of Kidney Disease Drug Kremezin: TFDA Orders Withdrawal of 1.38 Million Tablets from 2 Batches

According to a report by Central News Agency, Taiwan's Food and Drug Administration (TFDA) has announced a recall of two batches (TT24Y05, TT24Z13) of Kremezin Tablets 500mg, a uremic adsorbent used by chronic kidney disease patients, due to deviations in the testing method for residual solvents (ethanol) during the manufacturing process. The product, imported by Hsing Chang Pharmaceutical Co., Ltd., is approved under the license number MFDS-028080 and contains spherical absorptive carbon as its active ingredient.

The TFDA stated that on May 28, it received notification from the importer that the original manufacturer had identified a deviation in the solvent residue testing protocol. Although products manufactured during the affected period met specifications and no adverse events have been reported, the agency initiated a preventive recall to ensure drug quality and patient safety.

The recall must be completed by July 1, 2026. The company is required to submit a full investigation report and corrective action plan. Failure to comply may result in fines ranging from NT$200,000 to NT$5 million under Article 91 of the Pharmaceutical Affairs Act.

The TFDA confirmed that unaffected batches remain in sufficient inventory and will continue to be imported, ensuring no shortage of supply for patients.