BDS N

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Out-of-specification results were found in archival samples regarding the content of budesonide-related substances, due to exceeded levels of impurities. Potential effects: reduced treatment effectiveness or adverse effects related to the presence of impurities.

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Risk Level

Medium

Manufacturer

Apotex Europe B.V. z siedzibą w Holandii

Notice Date

20.08.2019

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Do not use the medicine from the withdrawn batches, check the batch number of the product you have and, if it is covered by the decision, return the medicine to the pharmacy and consult a doctor or ph...

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw the specified batches of the medicinal product BDS N from the market throughout the country and imposed an obligation to immediately undertake ac...

Need Help?

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

BDS N

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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