Formoterol Easyhaler

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 quality defect of the Easyhaler inhaler was found in the reservoir chamber containing the inhalation powder; the impact of this defect on the quality and correct dosing of the medicinal products cannot be excluded, creating a potential risk to patients’ health or life. Potential effects: lack of efficacy, disease exacerbation, respiratory complications.

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Risk Level

High

Manufacturer

Orion Corporation w Finlandii

Batch Number

2006402

Notice Date

03.03.2021

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 Formoterol Easyhaler and Bufomix Easyhaler inhalers from batches 2006402, 2035257 and 2032584. Check the batch number of the product you have; if it matches, return it to the pharmacy and c...

Actions Taken

The specified batches of Formoterol Easyhaler and Bufomix Easyhaler were withdrawn from the market nationwide and the decision was given immediate enforceability; the marketing authorisation holder wa...

Need Help?

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

Formoterol Easyhaler

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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