Gentamicin B.Braun

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Cross-contamination of infusion solutions was identified in numerous batches of B. Braun products, meaning the presence of incorrect active substances or their residues in bottles intended for intravenous administration, breaching quality and safety requirements. Potential effects: severe adverse reactions, poisoning, lack of efficacy or complications of intravenous therapy.

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Risk Level

Critical

Manufacturer

B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Niemcy

Batch Number

22037416

Notice Date

04.08.2023

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 listed batches of B. Braun infusion solutions. Check batch numbers and GTINs and return products covered by the decision to a (hospital) pharmacy. If a batch has been administered, moni...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of B. Braun infusion solutions from the national market and granted the decision immediate enforceability, following notification of c...

Need Help?

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

Gentamicin B.Braun

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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