Qutiro

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

Q: Which batches are affected?

Affected batch numbers: GL23G-03

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

Recall Date

28.03.2024

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: GL23G-03

Qutiro

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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