Popular Medication Removed from Store Shelves Due to Quality Defect
A widely sought-after medication used for the treatment of chest pain caused by coronary artery disease has been withdrawn from the market due to a quality defect, reported Economx.
The National Public Health and Medicinal Product Office (Nemzeti Népegészségügyi és Gyógyszerészeti Központ - NNGYK) has removed a batch with the serial number K91280623 of the PREDUCTAL PROLONG 80 MG RETARD HARD CAPSULES (OGYI-T-8844/05) from circulation due to quality issues, Economx noted.
According to the justification for the decision, a quality defect report was received by the NNGYK on February 28, 2024, concerning the aforementioned batch of the medicine, which did not comply with the European Directive on the prevention of falsified medicines.
Specifically, the packaging of the product lacks the unique identifier, i.e., the two-dimensional (2D) barcode, which enables the identification of the specific medicine batch and verifies the product's authenticity.
In view of the above, as well as further assessment of the available documentation, the NNGYK initiated ex officio proceedings on February 29, 2024, which resulted in the decision to withdraw the medication from the market.
The costs associated with the withdrawal and recall of the medication are to be borne by the marketing authorization holder.
According to the justification for the decision, a quality defect report was received by the NNGYK on February 28, 2024, concerning the aforementioned batch of the medicine, which did not comply with the European Directive on the prevention of falsified medicines.
Specifically, the packaging of the product lacks the unique identifier, i.e., the two-dimensional (2D) barcode, which enables the identification of the specific medicine batch and verifies the product's authenticity.
In view of the above, as well as further assessment of the available documentation, the NNGYK initiated ex officio proceedings on February 29, 2024, which resulted in the decision to withdraw the medication from the market.
The costs associated with the withdrawal and recall of the medication are to be borne by the marketing authorization holder.
AI Disclaimer: An advanced artificial intelligence (AI) system generated the content of this page on its own. This innovative technology conducts extensive research from a variety of reliable sources, performs rigorous fact-checking and verification, cleans up and balances biased or manipulated content, and presents a minimal factual summary that is just enough yet essential for you to function as an informed and educated citizen. Please keep in mind, however, that this system is an evolving technology, and as a result, the article may contain accidental inaccuracies or errors. We urge you to help us improve our site by reporting any inaccuracies you find using the "Contact Us" link at the bottom of this page. Your helpful feedback helps us improve our system and deliver more precise content. When you find an article of interest here, please look for the full and extensive coverage of this topic in traditional news sources, as they are written by professional journalists that we try to support, not replace. We appreciate your understanding and assistance.
