Bupivacaine Hydrochloride in Dextrose Injection USP

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 defective ampoule may crumble, creating a risk of glass particles entering the anaesthetic solution administered to the patient and of being unable to use the medicine during surgery. Potential effects: tissue damage from glass, surgical complications, life-threatening risk, lack of effective anaesthesia.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

App Store Google Play

Bupivacaine Hydrochloride in Dextrose Injection USP

Risk Level

Critical

Manufacturer

RemDcion Healthcare International, Indie, podmiot, który uzyskał zgodę Ministra Zdrowia na czasowe dopuszczenie do obrotu produktu leczniczego: ZF Polpharma S.A. Pass z siedzibą w Pass

Batch Number

V22192

Notice Date

10.01.2023

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 product from batch V22192, check the batch number on any packs held, return the product to the pharmacy or the marketing authorisation holder; if the medicine from this batch has been a...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch V22192 of this medicinal product from the market nationwide and granted the decision immediate enforceability.

Need Help?

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

Bupivacaine Hydrochloride in Dextrose Injection USP

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

Other Notices

Teicoplanin AptaPharma

Teicoplanin AptaPharma

Azaneson

Imuldosa

Loperamid APTEO MED