Ranigast

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The presence of N-nitrosodimethylamine (NDMA) contamination was confirmed in the active substance ranitidine used to manufacture batches of Ranigast 0.5 mg/ml, solution for infusion, which may pose a potential risk to patients' health. Potencjalne skutki: increased risk of adverse effects, including possible carcinogenic action with long-term exposure.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Batch Number

W3010418

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 Ranigast 0.5 mg/ml, solution for infusion from the listed batches; if you possess this medicine, check the batch number and return it to a pharmacy or consult a doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Ranigast 0.5 mg/ml, solution for infusion from the market throughout the country and granted the decision immediate enforceability,...

Need Help?

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

Ranigast

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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