Spasmolina

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

The non-compliance consisted in not placing on the packaging of prescription medicinal products the safety features: a unique identifier and an anti-tampering device. Potential effects: falsification of the medicine, misidentification, risk of lack of appropriate treatment.

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Risk Level

High

Manufacturer

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

Batch Number

010119

Notice Date

16.12.2019

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

Patients may use the listed batches according to their doctor’s instructions; there is no need to return them, it is only recommended to verify that the batch numbers match the information in the deci...

Actions Taken

After confirming that the deficiencies in packaging safety features were corrected, the decision to withdraw the specified medicinal product batches from the market was revoked.

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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