Mebelin

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Testing by the National Medicines Institute showed that the product does not meet quality requirements: release of mebeverine hydrochloride after 2, 8 and 12 hours was below the lower acceptance limit, which affects the effectiveness of the medicine. Potential effects: reduced effectiveness in treating intestinal complaints and possible worsening of disease symptoms.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

App Store Google Play

Risk Level

Medium

Manufacturer

Aristo Pharma sp. z o.o., z siedzibą w Warszawie

Batch Number

EMBCD1002A, wszystkie serie

Notice Date

30.10.2023

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 Mebelin with the specified GTIN numbers (all batches). Patients should consult a doctor or pharmacist regarding continuation of therapy and possible replacement of the medicine at the pharm...

Actions Taken

The Chief Pharmaceutical Inspector withdrew Mebelin from the market throughout the country for all batches, granted the decision immediate enforceability, and had previously sent the product for quali...

Need Help?

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

Mebelin

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

Other Notices

Teicoplanin AptaPharma

Teicoplanin AptaPharma

Azaneson

Imuldosa

Loperamid APTEO MED