The TFDA issued a safety alert, and ordered a local drug manufacture, Macro Global Corp., to recall “Rixia Tablets 0.5mg” on grounds of low API content.  About 980,000 tablets should be recalled.  The TFDA assures patients of their access to drugs as there are other alternatives available.  Patient currently holding the products in question should discuss the change of medication with their doctors as soon as possible.

This product recall affects two batches of “Rixia Tablets 0.5mg” (Batch number: A1Y65 and U3Y96).  Rixia contains metolazone and is indicated for hypertension.  The TFDA’s test results show that the API content of Batch A1Y65 is just 80%, while the API content of Batch U3Y96 is also quite low (91.5%).

According to the TFDA, there are 980,000 tablets in these two problem batches.  In 2021, total 1.81 million tablets of Rixia were reimbursed by the NHI.  The TFDA has issued 6 licenses to drugs identical to Rixia in ingredients, contents and dosage form.  Therefore, there is no need for patients to worry about the shortage of drug supply.   Patients affected by this product recall should discuss with their doctors about the change of medication.

The TFDA also demanded the manufacturer to launch an investigation to find out why the API content dropped significantly before the expiry date.  The manufacturer has to submit the investigation report before the mid of July and complete the product recall before August 9.  Otherwise, the manufacturer could be fined NT$200,000 ~ NT$5,000,000 according to Article 91 of the Pharmaceutical Affairs Law.

【2022-06-22 / China Times】