REMUREL

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 was found that the tested sample of the medicinal product does not meet the manufacturer's specification regarding the parameter: contamination with particles invisible to the naked eye. Potential effects: complications after injection, inflammatory reactions, lack of treatment safety.

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Risk Level

Critical

Manufacturer

Alvogen IPCo S.ar.l.

Batch Number

1802222G

Notice Date

05.06.2019

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 batch 1802222G, check the batch number on the packaging and return the product to the pharmacy or the marketing authorization holder; if it has been used and any worrying s...

Actions Taken

After identifying a quality defect, the Chief Pharmaceutical Inspector issued a decision to withdraw batch 1802222G of Remurel from the market and granted the decision immediate enforceability, obligi...

Need Help?

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

REMUREL

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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