Nitroxolin forte

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An impurity 5,7-Dinitro-8-quinolinol (DNC) was identified in the active substance and classified as a mutagenic impurity, whose content should be lower than currently approved limits. Potential effects: increased risk of DNA damage, cancer and other complications.

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Risk Level

High

Manufacturer

MIP Pharma Polska Sp. z o.o.

Batch Number

wszystkie serie

Notice Date

25.02.2021

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 medicine from any batch, check the product name, return any packages to a pharmacy, and consult a doctor or pharmacist if in doubt.

Actions Taken

Withdrawal from the market throughout the country of all batches of the medicinal product Nitroxolin forte and granting the decision immediate enforceability.

Need Help?

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

Nitroxolin forte

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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