BIOFLEKS 0.9% Isotonic Sodium Chloride Sterile, Natrii chloridum, 9 mg/ml, solution for infusion

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

Initially, the presence of liquid between the primary container and the outer foil was observed, raising suspicion of a quality defect; however, NIL testing confirmed that the product complies with requirements and poses no risk to patients. Potential effects: no identified health risk.

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BIOFLEKS 0.9% Isotonic Sodium Chloride Sterile, Natrii chloridum, 9 mg/ml, solution for infusion

Risk Level

Critical

Batch Number

24304201, 24304202, 24304204, 24304205, 24474643, 24474645

Notice Date

25.11.2025

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

The product may be used in accordance with the Summary of Product Characteristics; there is no need to return the specified batches or take additional actions by patients or distributors.

Actions Taken

State quality testing of the product was carried out by NIL, its compliance with requirements was confirmed, and the Chief Pharmaceutical Inspector declared the suspension decision for the specified b...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

BIOFLEKS 0.9% Isotonic Sodium Chloride Sterile, Natrii chloridum, 9 mg/ml, solution for infusion

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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