Bupivacaine Hydrochloride in Dextrose Injection USP

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

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.

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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

Recall Date

10.01.2023

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: V22192

Bupivacaine Hydrochloride in Dextrose Injection USP

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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