SPASMOLINA

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Incorrect expiry date was printed on outer packaging and required safety features (unique identifier and anti-tampering device) were missing, combined with lack of batch certification and release by the Qualified Person. Potential effects: lack of treatment efficacy, use of the product after expiry date, risk of falsification or tampering, treatment complications.

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Risk Level

High

Manufacturer

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

Batch Number

091016; 010119; 040219; 050219

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 indicated product batches, check the batch number and expiry date on the packaging, and if you possess these batches return them to the pharmacy or wholesaler; in case of any doubts abo...

Actions Taken

The Chief Pharmaceutical Inspector withdrew from the market the medicinal products Spasmolina 60 mg hard capsules (batches: 091016, 010119), Andepin 20 mg hard capsules (batch: 010119), and Kalium eff...

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

Recommendations

Actions Taken

Need Help?

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