RANIGAST PRO

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.

This risk may be caused by the potential presence of N-nitrosodimethylamine (NDMA) contamination in the medicinal product, which may affect human health and life. Potential effects: poisoning, carcinogenic effects.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

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 Ranigast Pro 75 mg from any batch; check any packages you have and return them to a pharmacy or consult a doctor to choose an alternative treatment.

Actions Taken

All batches of the product were suspended from the market nationwide; the decision was given immediate enforceability; the marketing authorization holder was obliged to promptly take actions related t...

Need Help?

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

RANIGAST PRO

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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