BENODIL

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Test results out of specification: elevated related substances content of budesonide. Potential effects: reduced efficacy, increased risk of adverse reactions.

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Risk Level

Medium

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Notice Date

07.02.2019

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 products from the affected batches; return them to the pharmacy or to the marketing authorisation holder; contact a doctor if concerned or if adverse effects occur.

Actions Taken

Decision of the Chief Pharmaceutical Inspector to withdraw the specified batches from the national market; order to take immediate actions in accordance with the Ministry of Health regulation.

Need Help?

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

BENODIL

What to do if you have this product?

What You Should Know

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Actions Taken

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