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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An out-of-specification result was found in the ongoing stability study after 18 months for the parameter: degree of release of the active substance (Chlordiazepoxide). Potential effects: possible lack of therapeutic efficacy, risk of worsening of disease symptoms.

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Risk Level

Medium

Manufacturer

TARCHOMIŃSKIE ZAKŁADY FARMACEUTYCZNE „POLFA” S.A. z siedzibą w Warszawie

Batch Number

50120

Notice Date

07.12.2021

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 product from batch 50120, check the batch number on the packaging, and if you possess this batch, return it to the pharmacy or consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 50120 of Elenium from the market throughout the country and 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

Need Help?

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