BIOFLEKS % 0.9 Izotonik Sodyum Klorür çözeltisi Steril

GIF decision: Marketing suspension

What does this decision mean?

  • Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Observed presence of liquid between the primary container and outer film of unknown origin, indicating possible leakage of a parenteral container. Potential effects: infection, loss of sterility, unpredictable consequences upon administration.

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BIOFLEKS % 0.9 Izotonik Sodyum Klorür çözeltisi Steril
Risk Level
High
Manufacturer
OSEL Ilac San. Ve Tic. A.S.; podmiot, który uzyskał zgodę MZ: InPharm sp. z o.o. z siedzibą w Warszawie
Batch Number
24304201, 24304202, 24304204, 24304205, 24474643, 24474645
Notice Date
18.10.2024
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 products from the listed batches; check the batch number before use; return products to the pharmacy or wholesaler; contact a doctor or pharmacist if in doubt.

Actions Taken

Suspension of distribution nationwide for the listed batches; decision made immediately enforceable; further investigative proceedings to be carried out.

Need Help?

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

Related

Other Notices