Montelukast Bluefish

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 discrepancy was found between the outer packaging and the Summary of Product Characteristics – a product intended for children aged 6–14 years was labelled as for children 2–5 years, which poses a threat to public health. Potential effects: improper use in children, risk of lack of efficacy or adverse effects.

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Risk Level

High

Manufacturer

Bluefish Pharmaceuticals AB, Szwecja

Batch Number

19E528

Notice Date

22.04.2020

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 medicine from batches 19E528, 19E529, 19E530, 19E531. Check the batch number on the packaging; if you have the product, return it to the pharmacy and consult a doctor or pharmacist if i...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of the medicinal product from the entire country and granted the decision immediate enforceability; the marketing authorisation holder...

Need Help?

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

Montelukast Bluefish

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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