Flutixon Neb

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An out-of-specification result was found for the content of related substances in the product batches, which constitutes a quality defect and a potential risk to patients' health. Potential effects: possible adverse reactions, altered treatment efficacy, unpredictable bodily responses.

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Risk Level

Medium

Manufacturer

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów

Batch Number

1151118

Notice Date

14.06.2021

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

Do not use Flutixon Neb from batches 1151118 and 1160418, check the batch number on the packaging, and consult a doctor or pharmacist if in doubt.

Actions Taken

Withdrawal from the market throughout the country of Flutixon Neb medicinal product batches 1151118 and 1160418, and granting the decision immediate enforceability.

Need Help?

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

Flutixon Neb

What to do if you have this product?

What You Should Know

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Actions Taken

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