Tadalafil Aurovitas

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Tests by the National Medicines Institute showed that the product does not meet quality requirements due to a negative result for the parameter “release of tadalafil within 15 minutes”, which may mean improper release of the active substance from the tablet. Potential effects: lack of treatment efficacy.

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Risk Level

Medium

Manufacturer

Aurovitas Pharma Polska sp. z o.o., ul. Sokratesa 13D lokal 27, 01-909 Warszawa

Batch Number

TGSD21011-A

Notice Date

09.10.2023

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use this medicinal product until the matter is clarified; patients should verify the name and strength of the medicine and consult a doctor or pharmacist regarding further therapy.

Actions Taken

Distribution of the medicinal product Tadalafil Aurovitas 20 mg, film-coated tablets, has been suspended throughout the country, with the decision given immediate enforceability.

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Tadalafil Aurovitas

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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