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.

After Qutiro infusion, patients developed chills, chest pain and seizures; blood cultures grew Klebsiella pneumoniae ESBL, indicating infection and a real threat to health or life. Potential effects: sepsis, septic shock, severe complications, death.

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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 (m.in. GL23G-03)

Notice Date

29.03.2024

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 Qutiro 5 mg/100 ml from any batch. Healthcare facilities should immediately stop its use and apply an alternative medicinal product. Patients who experienced worrying symptoms after adminis...

Actions Taken

The Chief Pharmaceutical Inspector suspended the marketing of Qutiro 5 mg/100 ml (all batches) throughout the country and temporarily prohibited placing it on the market, granting the decision immedia...

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

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Actions Taken

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