Qutiro

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

In patients after infusion of the product, chills, chest pain and generalized convulsions occurred; blood cultures grew Klebsiella pneumoniae ESBL, and the inspector indicated a real threat to patients’ health or life. Potential effects: severe bloodstream infections, septic shock, 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, 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 product. Check the product name and withdrawn batches, and immediately return any unused packs to a pharmacy or the marketing authorisation holder. If signs of infection or serious adv...

Actions Taken

The Chief Pharmaceutical Inspector withdrew all batches of Qutiro 5mg/100ml from the market throughout the country, prohibited their placing on the market, and granted the decision immediate enforceab...

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

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