Bupivacaine and Epinephrine, Bupivacaine-Epinephrine 0,5%,

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.

A change in solution colour from clear to opalescent, brown or yellow was reported. Product with changed colour must not be used and must be discarded; it is a solution for injection. Potential effects: possible toxic action or lack of anaesthetic efficacy, adverse reactions after injection.

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Bupivacaine and Epinephrine, Bupivacaine-Epinephrine 0,5%,

Risk Level

Critical

Manufacturer

Genetek Lifesciences PVT. LTD.; podmiot, który uzyskał zgodę MZ: ASCLEPIOS Spółka Akcyjna, z siedzibą we Wrocławiu;

Batch Number

124076

Notice Date

25.03.2025

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 124076, check the batch number, and return unused vials to a pharmacy or wholesaler. If a discoloured solution has been administered, monitor the patient and immediately ...

Actions Taken

The medicinal product batch 124076 was withdrawn from the market throughout the country and the placing of this batch on the market was prohibited; the decision was given immediate enforceability.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 and Epinephrine, Bupivacaine-Epinephrine 0,5%,

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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