Symibace

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Stability studies showed a significantly exceeded content of impurity B; the authority indicated that any exceedance of specification limits constitutes a real and direct threat to patients’ health or life. Potential effects: poisoning, serious adverse reactions, life-threatening events.

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Risk Level

Critical

Manufacturer

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

Batch Number

28C012A,

Notice Date

20.10.2023

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 from batches 28C012A and 14S012A. Check the batch number on the packaging and, if you have these batches, return them to the pharmacy. If the drug has been taken and adverse sympto...

Actions Taken

The Chief Pharmaceutical Inspector suspended the distribution nationwide of Symibace batches 28C012A and 14S012A and granted the decision immediate enforceability in order to conduct further investiga...

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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