Biotrakson

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 out-of-specification result for the endotoxin parameter was found in archival samples of an injectable product, which may pose a real and highly probable risk to patients’ health or life. Potential effects: poisoning, severe systemic reactions, septic complications.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Batch Number

25020921A

Notice Date

12.04.2022

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 the product from the listed batches, check the batch number of any possessed medicine and return it to the pharmacy; if the medicine from these batches has been used, contact a doctor.

Actions Taken

Withdrawal from the market throughout the country of the specified batches of the medicinal product and granting the decision immediate enforceability.

Need Help?

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

Biotrakson

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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