PALIFREN LONG

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.

A reduced content of the active substance paliperidone palmitate and an increased particle size compared to requirements were found, which may lead to reduced medicinal efficacy and a risk to patient health. Potential effects: reduced treatment efficacy, worsening of disease symptoms.

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PALIFREN LONG
Risk Level
Medium
Manufacturer
Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów
Batch Number
4201120
Notice Date
16.06.2023
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 the medicine from the listed batches; if you have any packs, check the batch number and consult a doctor or pharmacist to determine further steps.

Actions Taken

The PALIFREN LONG batches 4201120, DAR4201120, S000001943 and 4300099 were suspended from the market throughout the country and the decision was given immediate enforceability; the marketing authorisa...

Need Help?

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

Related

Other Notices