SPASMOLINA

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Incorrect expiry date marking was detected (“09.2019” instead of “10.2019”) and the product was reintroduced to the market after repackaging without the required certification and batch release by the Qualified Person. Potential effects: lack of treatment effectiveness or risk of using the product after its actual expiry date.

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Risk Level

Medium

Manufacturer

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

Batch Number

091016

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 the product from batch 091016 with expiry date 10.2019, check the batch number on the packaging and, in case of doubt, consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw Spasmolina 60 mg, hard capsules, batch number 091016, expiry date 10.2019, from the market.

Need Help?

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

SPASMOLINA

What to do if you have this product?

What You Should Know

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Actions Taken

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