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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The quality defect consists in labelling Benodil 0.25 mg/ml ampoules with Budixon Neb 0.5 mg/ml labels, which may mislead regarding the dose and use of the medicine. Potential effects: incorrect dosing, lack of therapeutic efficacy, or risk of complications in patients requiring an accurate corticosteroid dose.

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Risk Level

High

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Starogard Gdański

Batch Number

054223

Notice Date

17.11.2023

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 product from batch 054223, check the batch number on the packaging and return the medicine to the pharmacy; if it has been used, consult a doctor.

Actions Taken

Withdrawal of batch 054223 from the market throughout the country, prohibition of placing this batch on the market, and granting the decision immediate enforceability.

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

Recommendations

Actions Taken

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