Paracetamol Aflofarm

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

Problem achieving a homogeneous suspension and residual sediment at the bottom of the bottle despite shaking; product information lacked a specified minimum shaking time. Potential effects: uneven dosing and reduced efficacy, risk of incorrect dosing.

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Risk Level

High

Manufacturer

Aflofarm Farmacja Polska sp. z o.o. z siedzibą w Pabianicach

Batch Number

04AF0622, 01AF1122, 01AF1022, 02AF1022, 01AF0222

Notice Date

19.11.2024

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

Check the product batch number; shake vigorously and evenly before use (follow the updated leaflet specifying the minimum shaking time). If in doubt, contact a pharmacist or doctor and do not use the ...

Actions Taken

The prior GIF decision suspending product distribution was overturned and the proceedings were discontinued. An inspection and sediment dispersion tests were conducted; the marketing authorisation hol...

Need Help?

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

Paracetamol Aflofarm

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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