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.

It was found that the specification limit for contamination (Impurity B) in batch 49N013A was exceeded, which means failure to meet established quality requirements and represents a real and probable risk to patients’ health. Potential effects: adverse reactions, treatment complications, possible deterioration of health.

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Risk Level

High

Manufacturer

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

Batch Number

49N013A

Notice Date

13.09.2024

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 5 mg from batch 49N013A, check the batch number on the packaging, and return any packages held to a pharmacy; if the medicine from this batch has been taken, contact a doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 49N013A of Symibace 5 mg from the market throughout the country and prohibited its placing on the market, granting the decision immediate enforceabili...

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

Recommendations

Actions Taken

Need Help?

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