The Ministry of Food and Drug Safety has ordered recalls for specific batches of an antidepressant and a proton pump inhibitor due to a missing warning label and substandard potency.
The affected products are PMS Fluoxetine Capsules 20mg from Pharmascience Korea and Nexon Tablet 40mg from Teragen Itex.
Antidepressant Recall for Omitted Precautions
Pharmascience Korea is recalling its PMS Fluoxetine Capsules 20mg. The recall is for batch number 652698, with an expiration date of January 9, 2027. The reason for the recall is that some usage precautions required to be listed in the attached documents were omitted. This recall affects only this specific batch number and is not a recall of all PMS Fluoxetine Capsules 20mg products.
Acid Reducer Recall for Incorrect Potency
Teragen Itex is recalling its Nexon Tablet 40mg. The recall targets batch number 25001, which has an expiration date of May 29, 2028. The product is packaged in 28-count units (14 tablets/Alu-Alu x 2). The recall was triggered by findings from post-marketing stability tests that confirmed the product’s potency did not meet the required standards. This recall is limited to the specified batch number.
According to a Ministry of Food and Drug Safety official, while both recalls target specific batch numbers, the reasons are different. The PMS Fluoxetine is a case of omitted usage precautions in the attached documents, whereas the Nexon Tablet is a case of confirmed inappropriate potency from post-marketing stability tests,
the official explained.
The official added that pharmacies and medical institutions must verify both the product name and the batch number to accurately determine if their products are subject to the recall.
- More information is available on the Kpanews website.
