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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Lack of a unique identifier and tamper‑evident feature, together with incorrect expiry date labelling, may prevent proper medicine identification and facilitate circulation of unauthorised or expired packs. Potential effects: lack of treatment efficacy or complications related to use of expired or falsified medicine.

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Risk Level

High

Manufacturer

Przedsiębiorstwo Farmaceutyczno-Chemiczne SYNTEZA Sp. z o.o.

Batch Number

091016; 010119

Notice Date

26.04.2019

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 product from batches 091016 and 010119, check the batch number on the package and, if in possession, return the medicine to the pharmacy or wholesaler; in case of any doubts regarding the m...

Actions Taken

The Chief Pharmaceutical Inspector withdrew from the market the medicinal product Spasmolina 60 mg hard capsules, batch number 091016 (expiry 10.2019) and batch number 010119 (expiry 01.2022), due to ...

Need Help?

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

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What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

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