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.

The above decisions were issued due to a justified suspicion that certain batches of the product did not meet established quality requirements, owing to the inability to obtain a homogeneous suspension and the presence of sediment at the bottom of the bottle despite repeated shaking. Potential effects: possible improper dosing and reduced treatment efficacy.

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Risk Level

High

Manufacturer

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

Batch Number

04AF0622

Notice Date

17.01.2025

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

Patients may use the product in accordance with the current leaflet; before use, the bottle should be shaken vigorously for at least 30 seconds. If there are any doubts about the appearance of the med...

Actions Taken

The Chief Pharmaceutical Inspector’s decisions to suspend marketing of the specified batches were revoked. The information leaflets were updated regarding the shaking procedure for the suspension, and...

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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