Mebelin

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.

Tests by the National Medicines Institute showed that the product does not meet the quality specification for mebeverine hydrochloride release – release after 2, 8 and 12 hours was below the lower acceptance limit, affecting the product’s effectiveness. Potential effects: lack or reduction of therapeutic efficacy, possible worsening of disease symptoms.

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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 the product with GTIN 05909991425289 and 05909991425296; patients who have this medicine should consult a doctor or pharmacist to obtain suitable alternative therapy.

Actions Taken

Following the negative quality test results from the National Medicines Institute and a prior suspension of distribution, the Chief Pharmaceutical Inspector issued a decision banning the placing on th...

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?

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