Espumisan 100 mg/ml

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

In several packs of the product, information leaflets for the medicinal product Zentel were detected instead of the correct Espumisan leaflet. Potential effects: incorrect use of the medicine, risk of improper dosing or lack of treatment efficacy.

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Risk Level

High

Manufacturer

Importer równoległy: Forfarm Sp. z o.o.

Batch Number

51009A

Notice Date

10.01.2020

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 batch 51009A, check the batch number on the packaging and, if you have this product, return it to the pharmacy or consult a pharmacist/doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 51009A of Espumisan from the market throughout the country and granted the decision immediate enforceability, obliging the company to promptly carry o...

Need Help?

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

Espumisan 100 mg/ml

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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