Elenium

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The identified non-compliance in the parameter of active substance release affects the product’s quality and may impact its effectiveness and safety of use. The acceptance criterion for the minimum amount of released active substance was not met. Potential effects: possible lack of treatment efficacy and related disease complications.

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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 tablets from the listed batches, check the batch number on the packaging and return the product to a pharmacy; if you have concerns about your therapy, contact a doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Elenium from the entire national market, prohibited their placing on the market, granted the decision immediate enforceability, and...

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

Need Help?

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