Contents
The Main Pharmaceutical Inspectorate ordered the withdrawal of two series of the drug used in erectile dysfunction from pharmacies throughout Poland. They are Tadalafil Aristo 5 mg and 20 mg tablets. According to the GIF, it cannot be ruled out that the product “may pose a risk to the health of the patient”. The inspector’s decision is immediately enforceable. What specific series was withdrawn from sale and why?
- On July 12, 2022, the Main Pharmaceutical Inspectorate withdrew two series of the drug used in erectile dysfunction – Tadalafil Aristo throughout the country
- The reason for the recall of the Tadalafil Aristo series was the finding of a quality defect
- »(…) it should be concluded (…) that it cannot be ruled out that leaving the medicinal product in question on the market may pose a threat to the patient’s health» states the GIF
- More information can be found on the Onet homepage
Why was the erection drug Tadalafil Aristo withdrawn from sale?
The decision (no. 17) to withdraw Tadalafil Aristo tablets was taken by the Main Pharmaceutical Inspectorate on July 12. As we read in the announcement, the GIF received a letter from the representative of the Marketing Authorization Holder, requesting the withdrawal from the market of two series of the already mentioned product used in erectile dysfunction.
The reason is “non-compliance with good manufacturing practices by one of the manufacturers of the medicinal product”, which resulted in the suspension of the GMP (Good Manufacturing Practices) certificate. Moreover, the MAH notification was supported by the opinion of the manufacturer / importer, Aristo Pharma GmbH, who recommended a batch recall of Tadalafil Aristo.
The rest of the article is available under the video.
“In view of the above, it should have been deemed to be sufficiently substantiated that it cannot be ruled out that leaving the medicinal product in question on the market may pose a threat to the patient’s health” – informs the Main Pharmaceutical Inspectorate.
Are you struggling with erectile dysfunction? Or maybe you feel weak and have been feeling unwell for a long time? Be sure to check your health. E-packet for men – preventive blood tests available on Medonet Market will help you with this.
Which series of Tadalafil Aristo were withdrawn from pharmacies?
In accordance with the decision of the Main Pharmaceutical Inspectorate, two series of the drug used in erectile dysfunction are withdrawn from pharmacies throughout Poland. It is about:
Tadalafil Aristo (Tadalafilum), 5 mg, film-coated tablets, batch number: 1464005K expiry date: 30.04.2024/XNUMX/XNUMX
Tadalafil Aristo (Tadalafilum), 20 mg, coated tablets, batch number: 1462014C, expiry date: 31.05.2024/XNUMX/XNUMX, MAH: Aristo Pharma Sp. z o. o. with its seat in Warsaw.
Tadalafil Aristo. When is it used?
Tadalafil Aristo used to treat adult men with erectile dysfunction. The drug helps to widen the blood vessels of the penis, which allows blood to inflow and, as a result, improves erection.
The manufacturer states that “Tadalafil Aristo does not help patients who do not have erectile dysfunction”.
We encourage you to listen to the latest episode of the RESET podcast. This time Kamila Wykrota, the resilience trainer, will tell us about what resilience is. How does the ability to adapt to changing circumstances and react to adversities affect our quality of life? You will find out by listening to the latest episode of our podcast.