AVONEX

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Suspected quality defect of the immediate packaging of the specified batches, which may result in loss of tightness and a potential risk to patients’ health or life. Potential effects: infections, complications after administration of a non-sterile drug, lack of treatment efficacy.

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Risk Level

Critical

Manufacturer

Biogen Netherlands B.V.

Batch Number

1423235, 1423343

Notice Date

18.10.2019

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 batches 1423235 and 1423343. Patients should check the batch number, return the medicine to the pharmacy or physician, and if they have used medicine from these batches, co...

Actions Taken

The Chief Pharmaceutical Inspector withdrew Avonex batches 1423235 and 1423343 from the market throughout the country and granted the decision immediate enforceability; the marketing authorization hol...

Need Help?

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

AVONEX

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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