Clotidal MAX

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.

Negative test result for the appearance parameter – damaged, chipped tablet edges and detached fragments, probably due to too low water content in the granulate and lower hardness, which may affect dose integrity and comfort of use. Potential effects: reduced treatment efficacy or irritation.

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Risk Level

Medium

Manufacturer

US Pharmacia sp. z o.o. z siedzibą we Wrocław

Batch Number

01102382, 01092382, 01122382

Notice Date

15.01.2024

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

Patients may use the product according to the package leaflet; if they notice damaged tablets or have any doubts, they should contact a doctor or pharmacist.

Actions Taken

Marketing of the medicinal product was suspended, quality testing was commissioned at the National Medicines Institute and an explanatory procedure was conducted, after which the decision to suspend m...

Need Help?

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

Clotidal MAX

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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