Monover

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.

A clearly visible large piece of glass and glass particles were confirmed in a vial of the product, and their presence in other vials of the batch cannot be reliably excluded, while the medicine is administered intravenously. Potential effects: embolic complications, vessel damage, severe systemic complications, life-threatening events.

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Risk Level

Critical

Manufacturer

Pharmacosmos A/S z siedzibą w Danii

Batch Number

230504A-6

Notice Date

21.01.2025

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 the medicine from batch 230504A-6. Patients who have packs should check the batch number and return the product to a pharmacy and contact a doctor if the medicine has already been administe...

Actions Taken

The medicinal product Monover, batch 230504A-6, was withdrawn from the market throughout the country, the placing of this batch on the market was prohibited, and the decision was given immediate enfor...

Need Help?

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

Monover

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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