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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The identified non‑compliance in the active substance dissolution parameter affects product quality and may impact the effectiveness and safety of its use; a risk to human health cannot be excluded. Potential effects: lack of therapeutic effect, adverse reactions, health risk.

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Risk Level

Medium

Manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna z siedzibą w Warszawie

Batch Number

30122

Notice Date

09.04.2025

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 from the listed batches. If you have any packs, check the batch number and expiry date, then return the product to a pharmacy and consult a doctor or pharmacist if in doubt.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified Elenium batches from the market throughout the country, prohibited their placing on the market, granted the decision 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

Recommendations

Actions Taken

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