Palifren Long

GIF decision: Withdrawal from market, Marketing prohibition

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

An FDA inspection at the manufacturer found non-compliances in sterile/aseptic processing and procedures. Deviations in sterile manufacturing were detected, posing a risk to the quality of these medicinal products. Potential effects: infection after injection, poisoning, severe systemic complications.

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Risk Level

Critical

Manufacturer

Adamed Pharma S.A. z siedzibą w Pieńkowie

Batch Number

4500575, 4401275, 4400803, 4500970, 4500771, 4500442, 4401435, 4400975, 4501001, 4500827, 4500281, 4500097, 4400432, 4401151, 4401261, 4401098, 4401101, 4501375, 4501247, 4500835, 4500207, 4401407, 4400148, 4400147, 4301762, 4301763, 4401259, 4401260, 4400980, 4400804

Notice Date

23.12.2025

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 any of the listed batches of Palifren Long. Patients who have packs from these batches should contact their treating physician or pharmacist to determine further treatment and possible pro...

Actions Taken

Withdrawal from the market throughout the country of all specified batches of the medicinal product Palifren Long in doses of 50 mg, 75 mg, 100 mg and 150 mg. Prohibition on placing the listed batche...

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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