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.

The application explained that the manufacturer is preparing documentation on the root cause of the non-conformity, implemented corrective and preventive actions, and identified violations of the product’s quality requirements. Potential effects: possible reduced treatment effectiveness or occurrence of unexpected adverse reactions.

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Risk Level

Low

Manufacturer

Viatris Healthcare sp. z o.o. (uprzednio pod firmą: Mylan Healthcare sp. z o.o.) zs. w Warszawie

Batch Number

D1900226

Notice Date

10.05.2024

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

Do not use the batches subject to suspension. Check the batch number on the packaging; if you have these batches, consult a pharmacist or doctor and consider returning the product to the pharmacy.

Actions Taken

The nationwide marketing of the specified batches of Reparil Gel N was suspended, the decision was partially revoked for four batches, and the decision was granted immediate enforceability.

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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