Omegaflex special

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

An improperly made package seal allowed air and oxygen to enter the bag, which could change the medicine’s properties and lead to adverse health effects and a real risk to patients’ health and potentially also life. Potential effects: complications, lack of efficacy, possible severe 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 medicine from batch 234818231, check the batch number on the packaging and return the product to the pharmacy or hospital; if the medicine from this batch has been administered, consult a d...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 234818231 of Omegaflex special from the market nationwide, prohibited this batch from being placed on the market, and granted the decision immediate e...

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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