SOLVERTYL

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.

Suspicion of the presence of N-nitrosodimethylamine (NDMA) contamination in medicinal products with Ranitidinum, which may affect human health and life and poses a potential risk to patients. Potential effects: poisoning, carcinogenic effects, systemic complications.

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SOLVERTYL
Risk Level
Critical
Manufacturer
PharmaSwiss Ceska Republika s.r.o.
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 medicinal products containing Ranitidinum from the affected products/batches, check the medicine name and, in case of doubt, consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector preventively suspended from the market all medicinal products containing the active substance Ranitidinum, granting the decision immediate enforceability, and oblige...

Need Help?

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

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