Elenium

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A non-compliance of the active substance dissolution parameter was found in stability studies, meaning reduced and delayed drug release and uncertainty regarding the efficacy and safety of the tablets throughout their shelf life. Potential effects: lack of treatment efficacy, disease complications.

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Risk Level

Medium

Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.

Batch Number

10324

Notice Date

13.06.2025

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

Do not use Elenium tablets from batches 10324 and 50125, check the batch number on the packaging, and consult a doctor or pharmacist if in doubt.

Actions Taken

Withdrawal from the entire national market of Elenium batches 10324 and 50125 and a ban on placing these batches on the market, with the decision given immediate enforceability.

Need Help?

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

Elenium

What to do if you have this product?

What You Should Know

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