Palifren Long

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.

A justified suspicion of a quality defect of the medicinal product was identified, and its occurrence was subsequently confirmed in batches 4201120, 4300099 and 4201591. The nature of the defect is not specified in the decision. Potential effects: possible treatment complications, lack of efficacy or adverse reactions.

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Risk Level

Critical

Manufacturer

Adamed Pharma S.A. z siedzibą w Pieńkowie

Batch Number

4201120

Notice Date

01.07.2024

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 batches 4201120, 4300099 and 4201591. Check the batch number on the packaging and, if you have these batches, return the product to the pharmacy or consult a doctor.

Actions Taken

The marketing of the product was suspended due to a suspected quality defect, an investigation was carried out, then batches 4201120, 4300099 and 4201591 were withdrawn from the market, and the suspen...

Need Help?

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

Palifren Long

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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