Monural

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Use of the product, for which the benefit-risk balance was judged negative, poses a threat to public health and may directly endanger patients’ health or life. Potential effects: serious adverse reactions, lack of treatment efficacy, complications threatening health or life.

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Risk Level

Critical

Manufacturer

Zambon S.p.A. Włochy

Batch Number

wszystkie serie

Notice Date

17.06.2020

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. Check the medicine name, and if you have it, return it to the pharmacy and consult a doctor or pharmacist to choose an alternative therapy.

Actions Taken

The Chief Pharmaceutical Inspector temporarily prohibited placing the product on the market and withdrew all batches from the market nationwide, granting the decision immediate enforceability.

Need Help?

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

Monural

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

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