Bupivacaine WZF Spinal 0,5% Heavy

GIF decision: Withdrawal from market, Marketing prohibition

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Insoluble contaminants were detected in some ampoules of the injection solution, which may affect the quality, efficacy and safety of the medicinal product. Potential effects: complications during spinal anaesthesia, inflammatory reactions, lack of efficacy, serious health complications.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A. z siedzibą w Starogardzie Gdańskim

Batch Number

510424

Notice Date

08.07.2025

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 product from batch 510424, check the batch number on any packs held, return the medicine to a pharmacy or hospital; if already used, contact a doctor.

Actions Taken

The medicinal product batch 510424 was withdrawn from the market throughout the country, placing this batch on the market was prohibited, and the decision was given immediate enforceability.

Need Help?

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

Bupivacaine WZF Spinal 0,5% Heavy

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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