Tadalafil Aristo

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Non-compliance with Good Manufacturing Practice was found at one of the manufacturers, resulting in suspension of the GMP certificate, so it cannot be excluded that keeping the product on the market may pose a risk to patient health. Potential effects: possible risk to patient health, including lack of treatment efficacy or unpredictable adverse effects.

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Risk Level

Medium

Manufacturer

Aristo Pharma Sp. z o.o.

Batch Number

1464005K

Notice Date

12.07.2022

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 the product from batches 1464005K and 1462014C; patients should check the batch number and, if they possess these packs, return them to a pharmacy or consult a doctor or pharmacist to ensur...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batches 1464005K and 1462014C of Tadalafil Aristo from the market throughout Poland and granted the decision immediate enforceability, obliging the marketin...

Need Help?

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

Tadalafil Aristo

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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