SYDAFED XYLOSPRAY HA

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

It cannot be excluded that the product batch fails to meet quality requirements regarding sterility. Potential effects: risk of infections or other health complications.

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Risk Level

Critical

Manufacturer

McNeil Healthcare (Ireland) Limited z siedzibą w Irlandii

Notice Date

25.01.2019

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. Check the batch number and return the product to a pharmacy or contact the marketing authorization holder. Consult a doctor if you experience concerning symptoms.

Actions Taken

The marketing authorization holder voluntarily withdrew the batch; the Chief Pharmaceutical Inspector issued a decision to withdraw/ban placing the product on the market with immediate enforceability.

Need Help?

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

SYDAFED XYLOSPRAY HA

What to do if you have this product?

What You Should Know

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