Monover

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A visible large piece of glass of about 1 cm moving inside the vial and glass particles on the walls and neck of the vial of a product administered intravenously were detected. Potential effects: damage to blood vessels, embolism, thrombotic complications, severe systemic complications, life‑threatening conditions.

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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 medicine from batch 230504A-6, check the batch number on any packs you have and, if you possess this batch, return the product to the pharmacy and consult a doctor.

Actions Taken

Withdrawal from the market throughout the country of the medicinal product Monover for batch 230504A-6, prohibition of placing this batch on the market, and granting the decision immediate enforceabil...

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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