Monover

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.

A clearly visible large piece of glass (about 1 cm) was found moving inside the vial, as well as glass particles on the walls and neck of the vial of a product administered intravenously. Potential effects: severe vascular complications, embolism, tissue damage, life‑threatening complications.

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Risk Level

Critical

Manufacturer

Pharmacosmos A/S z siedzibą w Danii

Batch Number

230504A-6

Notice Date

22.08.2024

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 Monover from batch 230504A-6. Check the batch number of any vials held; return the product to a pharmacy or hospital. If the medicine from this batch has been administered, contact a doctor...

Actions Taken

Distribution of Monover batch 230504A-6 was suspended throughout the country and the decision was given immediate enforceability; further investigation is ongoing.

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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