BUDIXON NEB

GIF decision: Withdrawal from market

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  • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Exceeding the specification limit for the parameter of budesonide-related substances content was found, meaning the product does not meet established quality requirements. Potential effects: possible lack of treatment efficacy or adverse reactions.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

BUDIXON NEB
Risk Level
Medium
Manufacturer
Adamed Pharma S.A.
Notice Date
04.07.2019
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Do not use the product from the withdrawn batches, check the batch number of the medicine you have, and consult a doctor or pharmacist if in doubt.

Actions Taken

The Chief Pharmaceutical Inspector withdrew from the market throughout the country the batches of the medicinal product Budixon Neb with exceeded limits of budesonide-related substances content and gr...

Need Help?

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

Related

Other Notices