Misintu

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.

Visible to the naked eye, insoluble particles of unknown nature and origin were found in prepared solutions of the medicinal product in the form of an injection solution, which may create a real danger of these particles entering the patient's bloodstream. Potential effects: embolic complications, vascular damage, unpredictable systemic reactions.

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Risk Level

Critical

Manufacturer

Koçsel İlaç San. ve Tic. A.Ş. Turcja, podmiot, który uzyskał zgodę na czasowe dopuszczenie do obrotu produktu leczniczego: Genesis Pharm sp. z o.o. sp. komandytowa, Łódź.

Batch Number

30313010, 30845510

Notice Date

12.02.2024

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 the medicine from batches 30313010 and 30845510, check the batch number of any pack you hold, return the product to the pharmacy; if a dose from a defective batch was administered, contact ...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of the product from the entire national market, prohibited further placing of these batches on the market, and granted the decision im...

Need Help?

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

Misintu

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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