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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.

An incorrect print shortening the product expiry date by one month and reintroduction of the repackaged batch to the market without required certification and release by the Qualified Person may lead to use of the product after its actual expiry or with unverified quality. Potential effects: lack of efficacy or complications related to using the product after its 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, check the batch number on the packaging and, if you have this product, return it to the pharmacy; in case of doubts consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw from the market the medicinal product Spasmolina 60 mg hard capsules, batch number 091016, due to incorrect expiry date labelling and lack of re-...

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

Need Help?

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