OZURDEX

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

Q: Which batches are affected?

Affected batch numbers: E82467 (oraz wcześniejsze 7 serii wycofane decyzją nr 106AVC/2018)

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)

Recall Date

05.06.2019

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: E82467 (oraz wcześniejsze 7 serii wycofane decyzją nr 106AVC/2018)

OZURDEX

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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