Symibace

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  • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An exceedance of the specification limit for impurity B was found, which according to the authority represents a real and probable risk to human health. Potential effects: poisoning, complications, lack of treatment safety.

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Symibace
Risk Level
High
Manufacturer
Symphar sp. z o.o. z siedzibą w Warszawie
Batch Number
49N013A
Notice Date
13.09.2024
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 packs held to a pharmacy; if it has already been used, contact a doctor.

Actions Taken

The medicinal product Symibace 5 mg from batch 49N013A was withdrawn from the market throughout the country and placing this batch on the market was prohibited; the decision was given immediate enforc...

Need Help?

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

Related

Other Notices