RANITYDYNA AUROVITAS

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 medicinal products containing Ranitidinum, which may affect human health and life, posing a potential risk to patients. Potential effects: poisoning, carcinogenic effects, serious health complications.

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Risk Level

Critical

Manufacturer

Aurovitas Pharma Polska Sp. z o.o.

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 medicinal products containing Ranitidinum until the case is clarified; check whether your medicine contains this active substance and, in case of doubt, consult a doctor or pharmacist.

Actions Taken

Preventive suspension from the market of all medicinal products containing Ranitidinum and granting the decision immediate enforceability; obligating the company to take suspension/withdrawal actions ...

Need Help?

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

RANITYDYNA AUROVITAS

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