Ranigast Pro

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Contamination of the active substance Ranitidinum with N-nitrosodimethylamine (NDMA) was detected, representing a quality defect of the product and potentially endangering patients’ health or life. Potential effects: poisoning, carcinogenic effects, serious health complications.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Batch Number

10317

Notice Date

28.10.2019

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 the product from the listed batches; patients should check the batch number on the packaging and, if it matches, return the medicine to the pharmacy and consult a doctor regarding further t...

Actions Taken

Withdrawal from the market throughout the country of the specified batches of the medicinal product Ranigast Pro and imposition of immediate enforceability of the decision.

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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