Bupicain

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The information leaflet for Bupicain contains incorrect data on the possibility of intravenous and intra-arterial administration of the medicine, which is associated with a threat to public health. Potential effects: incorrect administration, severe complications, life-threatening events.

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Risk Level

Critical

Manufacturer

Monico SpA, podmiot, który uzyskał zgodę na czasowe dopuszczenie do obrotu produktu leczniczego: Shiraz Pharm Sp. z o.o., Ksawerów

Batch Number

21GA543, 21JA761, 21JA762, 21KA788

Notice Date

27.01.2023

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 the medicine from the listed batches. Check the batch number on the packaging and, if you have the product, return it to the pharmacy or doctor. If the medicine has been used, consult a doc...

Actions Taken

Withdrawal from the market throughout the country of the specified batches of the medicinal product Bupicain, with the decision given immediate enforceability.

Need Help?

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

Bupicain

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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