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.

Suspected microbiological contamination of the infusion solution, linked with detection of Klebsiella pneumoniae ESBL in patients’ blood cultures and serious unexpected adverse reactions (chills, chest pain, convulsions). Potential effects: sepsis, severe systemic reactions, life-threatening conditions.

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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; wcześniej zgłoszona seria: 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 5mg/100ml. Check the medicine name and, if you have this product, contact your doctor or pharmacist; if symptoms such as chills, chest pain or convulsions occur, seek medical attenti...

Actions Taken

Distribution of Qutiro 5mg/100ml was suspended throughout the country and a temporary ban on placing it on the market was imposed; the decision was given immediate enforceability.

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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