Omegaflex special

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An improperly made seal of the outer bag allowed air and oxygen to enter, which could change the properties of the lipid emulsion and poses a real risk to patients’ health and life. Potential effects: complications during infusion, lack of treatment efficacy, adverse reactions.

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Risk Level

Critical

Manufacturer

B. Braun Melsungen AG, z siedzibą Melsungen, Niemcy

Batch Number

234818231

Notice Date

27.03.2024

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 medicine from batch 234818231. Check the batch number and return any packs held to the pharmacy or the marketing authorisation holder. If the medicine from this batch has been administe...

Actions Taken

Withdrawal from the market across the entire country of batch 234818231 of Omegaflex special and a ban on placing this batch on the market, with the decision given immediate enforceability.

Need Help?

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

Omegaflex special

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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