Clatra

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.

The product does not meet quality requirements due to a negative test result for contamination with particles visible to the naked eye, which in sterile eye drops may pose a risk to the patient’s eye. Potential effects: eye irritation, mechanical damage, infection, ophthalmic complications.

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Clatra
Risk Level
Critical
Manufacturer
Menarini International Operations Luxembourg S.A. z siedzibą w Luksemburgu
Batch Number
wszystkie serie (m.in. 323550A)
Notice Date
24.04.2025
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 Clatra, Bilastinum, 6 mg/ml, eye drops, solution. Check the product name and return it to a pharmacy or doctor for refund or replacement; if any eye symptoms occur, contact a doctor.

Actions Taken

Following a negative quality test result from the National Medicines Institute, the Chief Pharmaceutical Inspector suspended the marketing of Clatra, Bilastinum, 6 mg/ml, eye drops, solution for all b...

Need Help?

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

Related

Other Notices