Benodil

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

there is a justified suspicion that the unit packs of the medicinal product contain a product with a significantly higher dose of active substance than indicated on the outer labelling, creating a real risk that patients will take several times the intended dose. Potential effects: overdose of inhaled medicine, increased corticosteroid side effects, complications in sensitive patients.

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Risk Level

High

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A. z siedzibą w Starogardzie Gdańskim

Batch Number

054223

Notice Date

10.11.2023

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

Actions Taken

Marketing of batch 054223 of Benodil 0.25 mg/ml, suspension for nebulisation, was suspended throughout the country and the decision was given 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

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Actions Taken

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