Qutiro

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

Q: Which batches are affected?

Affected batch numbers: wszystkie serie, w tym GL23G-03

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

Recall Date

23.07.2024

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Do not use this medicinal product from the withdrawn batches.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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

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: wszystkie serie, w tym GL23G-03

Qutiro

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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