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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.

Only a labelling error of the expiry date was found (02.2021 instead of 02.2020), with no indication of quality or safety hazards for the product. After confirmation of shelf-life extension to 3 years, the risk was considered negligible. Potential effects: none or minimal risk, possibly uncertainty about the actual expiry date.

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Risk Level

Low

Manufacturer

Polfarmex S.A.

Notice Date

26.03.2019

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 from batch 010218 may be used in accordance with the current 3-year shelf life; if there are any doubts about validity or quality, consult a pharmacist or physician.

Actions Taken

Initially, by decision of 20.04.2018, batch 010218 was withdrawn from the market due to incorrect expiry date labelling; subsequently, after amendment of the marketing authorization and confirmation o...

Need Help?

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

IRCOLON FORTE

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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