Qutiro

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.

In five patients after infusion of the product, chills and chest pain occurred and blood cultures grew Klebsiella pneumoniae ESBL; in another three patients, chills progressed to generalized convulsions. A real threat to patients’ health or life was indicated. Potential effects: severe bloodstream infection, septic complications, life‑threatening condition.

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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

wszystkie serie, w tym GL23G-03

Notice Date

23.07.2024

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Do not use this medicinal product from the withdrawn batches. Healthcare facilities should immediately withdraw it from use and return it to the wholesaler or supplier. Patients who experienced worryi...

Actions Taken

The Chief Pharmaceutical Inspector withdrew all batches of Qutiro from the market nationwide and prohibited its further placing on the market, granting the decision immediate enforceability; previousl...

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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