Reparil Gel N

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

Suspicion of failure to meet established quality requirements for the parameter “aescinol content”; out-of-specification stability results for representative batches indicated excessively high initial aescinol content in the finished product. Potential effects: possible reduced treatment effectiveness or increased adverse reactions.

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Risk Level

Medium

Manufacturer

Viatris Healthcare sp. z o.o. z siedzibą w Warszawie

Batch Number

D2001785

Notice Date

11.12.2024

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

The product may be used according to the leaflet and doctor’s recommendations; in case of doubts or any worrying symptoms, patients should contact a doctor or pharmacist.

Actions Taken

Distribution of the product was suspended nationwide due to suspected quality defect, administrative proceedings for withdrawal from the market were initiated, and subsequently the decision to suspend...

Need Help?

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

Reparil Gel N

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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