RANIBERL MAX

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.

Suspected presence of N-nitrosodimethylamine (NDMA) contamination in the medicinal product, which may affect human health and life. Potential effects: carcinogenic action, organ damage with long-term exposure.

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Risk Level

Critical

Manufacturer

Berlin-Chemie AG, Niemcy

Batch Number

wszystkie serie

Notice Date

19.09.2019

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 Raniberl Max (Ranitidinum) from any batch, check the name of the medicine used and, in case of doubt, contact a doctor to select alternative therapy. Pharmacies and wholesalers should suspe...

Actions Taken

All batches of Raniberl Max (Ranitidinum) were suspended from marketing throughout the country and the decision was given immediate enforceability; the marketing authorisation holder was obliged to ta...

Need Help?

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

RANIBERL MAX

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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