OZURDEX

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A silicone particle of about 300 µm in diameter was detected in some batches of the medicinal product Ozurdex, which constitutes a potential quality defect and may pose a risk to patients' health. Potential effects: complications after administration, tissue irritation, visual disturbances, serious ophthalmic complications.

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Risk Level

Critical

Manufacturer

Allergan Pharmaceuticals Ireland

Batch Number

E82467 (oraz wcześniejsze 7 serii wycofane decyzją nr 106AVC/2018)

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 Ozurdex from batch E82467 or from the batches covered by decision no. 106AVC/2018. Check the batch number and, if you have this medicine, return it to the pharmacy or your doctor and consul...

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw 7 batches of Ozurdex from the market (decision no. 106AVC/2018) and, after new defect-free batches were introduced, preventively withdr...

Need Help?

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

OZURDEX

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

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