Symibace

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.

Taking into account test results showing a significant exceedance of the specification limit for impurity B content, the risk to human health from leaving these medicinal product batches on the market is real and probable. Potential effects: toxicity, adverse reactions, therapeutic complications.

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Risk Level

High

Manufacturer

Symphar sp. z o.o. z siedzibą w Warszawie

Batch Number

14S012A

Notice Date

25.01.2024

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 Symibace tablets from the specified batches. Check the batch number on the packaging and, if you have the product, return it to the pharmacy or consult a doctor.

Actions Taken

The Symibace batches 28C012A (2.5 mg) and 14S012A (5 mg) were withdrawn from the market nationwide and their placing on the market was prohibited, with the decision given immediate enforceability.

Need Help?

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

Symibace

What to do if you have this product?

What You Should Know

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Actions Taken

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