Eptifab

Q: Is this product safe to consume?

No. This product has been recalled due to: Incorrect information in the leaflet was found: swapped dosing instructions for patients with normal and impaired renal function, which may lead to improper dosing of the injection solution and direct, serious health consequences. Potential effects: poisoning, severe bleeding complications, lack of treatment efficacy, life‑threatening events.

Q: Which batches are affected?

Affected batch numbers: LFH0031, LFH0033, LFH0034

Incorrect information in the leaflet was found: swapped dosing instructions for patients with normal and impaired renal function, which may lead to improper dosing of the injection solution and direct, serious health consequences. Potential effects: poisoning, severe bleeding complications, lack of treatment efficacy, life‑threatening events.

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Risk Level

Critical

Manufacturer

podmiot odpowiedzialny: Abbott Healthcare Private Limited z siedzibą w Indiach; podmiot, który uzyskał zgody na czasowe wprowadzenie do obrotu produktu leczniczego: Delfarma sp. z o.o. z siedzibą w Łodzi

Batch Number

LFH0031, LFH0033, LFH0034

Recall Date

29.08.2024

What You Should Know

Recommendations

Do not use Eptifab from batches LFH0031, LFH0033 and LFH0034. Check the batch number on the packaging; if the medicine from these batches has been used, contact a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batches LFH0031, LFH0033 and LFH0034 of Eptifab, 2 mg/ml, solution for injection from the entire Polish market, granted the decision immediate enforceabilit...

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: Incorrect information in the leaflet was found: swapped dosing instructions for patients with normal and impaired renal function, which may lead to improper dosing of the injection solution and direct, serious health consequences. Potential effects: poisoning, severe bleeding complications, lack of treatment efficacy, life‑threatening events.

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: LFH0031, LFH0033, LFH0034

Eptifab

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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