Axonalgin

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.

The product does not meet the requirements for chromatographic purity of metamizole sodium monohydrate: a single unspecified impurity and impurity E are present, exceeding the accepted specification. Potential effects: unpredictable adverse reactions, possible toxic effects or reduced efficacy of the medicine.

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Risk Level

Medium

Manufacturer

Aristo Pharma Sp. z o.o. z siedzibą w Warszawie

Batch Number

wszystkie serie (m.in. seria P2410092)

Notice Date

14.04.2025

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 medicine. Check the product name and dosage form, and return any packs in your possession to the pharmacy. If in doubt or if adverse symptoms occur, consult a doctor or pharmacist.

Actions Taken

The marketing of the medicinal product Axonalgin for all batches has been suspended throughout the entire country, and the decision was given immediate enforceability.

Need Help?

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

Axonalgin

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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