Tadalafil Aurovitas

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

The batch TGSD21011-A did not meet quality requirements due to a negative result for the parameter “release of tadalafil within 15 minutes”, which may affect treatment effectiveness. Potential effects: lack of therapeutic efficacy.

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Risk Level

Medium

Manufacturer

Aurovitas Pharma Polska sp. z o.o. z siedzibą w Warszawie

Batch Number

TGSD21011-A

Notice Date

29.12.2023

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

Patients may use the product according to the physician’s instructions; if they have any doubts about treatment effectiveness, they should contact their doctor or pharmacist.

Actions Taken

The product was sent for quality testing at the National Medicines Institute; based on the results, the Chief Pharmaceutical Inspector suspended its marketing nationwide with immediate effect, and lat...

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

Recommendations

Actions Taken

Need Help?

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