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  • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 in the specified batches of B. Braun medicinal products was detected and reported in the Rapid Alert system by the Hessian State Office for Health and Care. Potential effects: risk of incorrect dosing, toxicity, lack of therapeutic efficacy or serious complications after intravenous administration.

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Gentamicin B.Braun
Risk Level
Critical
Manufacturer
B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Niemcy
Batch Number
22166411
Notice Date
04.08.2023
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 products from the listed batches, check batch numbers and expiry dates, return the products to a pharmacy or hospital; if they have been administered to a patient, contact a doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of B. Braun medicinal products from the market nationwide and granted the decision immediate enforceability, following a notification ...

Need Help?

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

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Other Notices