Sugammadex Reig Jofre

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.

The submitted safety assessment report indicates that potential risk to patients from injection of visible silicone particles cannot be excluded. Potential effects: complications after injection, local or systemic reactions, health risk.

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Risk Level

Critical

Manufacturer

Reig Jofre sp. z o.o. z siedzibą w Warszawie

Batch Number

23203V

Notice Date

03.10.2024

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 product from batches 23203V and 24201. Check the batch number on the packaging and, if you have these batches, return the product to a pharmacy or doctor. If the product from a defectiv...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batches 23203V and 24201 of the product from the market throughout the country and prohibited their placing on the market, granting the decision immediate e...

Need Help?

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

Sugammadex Reig Jofre

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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