Qutiro

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.

In several patients after Qutiro infusion, chills, chest pain and convulsions occurred; blood cultures grew Klebsiella pneumoniae ESBL. A microbiological contamination of the sterile infusion product is suspected, posing a real threat to patients’ health or life. Potential effects: severe bloodstream infection, septic shock, life‑threatening complications.

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Risk Level

Critical

Manufacturer

QUESTUS PHARMA PRIVATE LIMITED z siedzibą w Indiach, podmiot, który uzyskał zgodę na czasowe dopuszczenie do obrotu ww. produktu leczniczego: Genesis Pharm sp. z o.o. sp. komandytowa, ul. Obywatelska 128/152, 94-104 Łódź

Batch Number

GL23G-03

Notice Date

28.03.2024

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 product from batch GL23G-03. Healthcare facilities should immediately withdraw this batch from use, separate it from other stocks, and monitor patients who received the drug, reporting ...

Actions Taken

The Chief Pharmaceutical Inspector suspended distribution of Qutiro 5mg/100ml batch GL23G-03 throughout the country, granted the decision immediate enforceability, and obliged the company to take acti...

Need Help?

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

Qutiro

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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