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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Exceedance of the specification limit for the content of budesonide related substances was found in one batch and there is a probability of exceeding this limit in other batches of the product. Potential effects: possible lack of efficacy, unpredictable drug action, therapy complications.

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Risk Level

Critical

Manufacturer

Adamed Pharma S.A.

Batch Number

060218 oraz inne wymienione w decyzji serie będące w terminie ważności (niewymienione w tym fragmencie)

Notice Date

01.08.2019

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 medicine from batches covered by the withdrawal decision; patients should check the batch number on the packaging and, if it matches, return the product to the pharmacy and consult a do...

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw the specified batches of Budixon Neb 0.5 mg/ml from the market throughout the country and granted the decision immediate enforceability...

Need Help?

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

BUDIXON NEB

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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