RANIGAST

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: possible carcinogenic effect, liver damage, other toxic complications.

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RANIGAST
Risk Level
Critical
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Batch Number
wszystkie serie
Notice Date
19.09.2019
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 (Ranitidine) 0.5 mg/ml solution for infusion, check your medicine, and if in doubt consult a doctor or pharmacist to choose an alternative treatment.

Actions Taken

All batches of Ranigast (Ranitidine) 0.5 mg/ml solution for infusion were suspended from the market nationwide and the decision was given immediate enforceability, obliging the marketing authorisation...

Need Help?

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

Related

Other Notices