Mebelin

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Due to the reduced values of active substance release in the product, the risk to patient health resulting from decreased drug efficacy cannot be excluded. Potential effects: lack of treatment efficacy, possible worsening of disease symptoms.

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Risk Level

Medium

Manufacturer

Aristo Pharma Sp. z o.o., ul. Baletowa 30, 02-867 Warszawa

Batch Number

wszystkie serie (m.in. EMBCD1002A)

Notice Date

26.06.2023

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 the indicated GTINs and any batches; patients should check their packs and, if they have this medicine, contact a pharmacy or doctor to return it or obtain an alternative.

Actions Taken

The Chief Pharmaceutical Inspector suspended from the market nationwide all batches of Mebelin and granted the decision immediate enforceability; the marketing authorisation holder was obliged to prom...

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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