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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It showed an out-of-specification result for the solution colour parameter. The product risk was assessed as RAS class II. Potential effects: possible reduced medicinal product quality, risk of treatment inefficacy or adverse reactions.

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Risk Level

Critical

Manufacturer

B. Braun Melsungen AG

Batch Number

22217413

Notice Date

17.11.2022

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 with batch number 22217413, check the batch number of any product held, return it to the pharmacy or supplier; in case of doubt, contact a doctor.

Actions Taken

Withdrawal from the market throughout the country of batch 22217413 of the medicinal product, granting the decision immediate enforceability, and initiation of the recall process by the marketing auth...

Need Help?

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

Tobramycin B. Braun

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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