Dicortineff

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Occurrence of a quality defect in the medicinal product in the fludrocortisone acetate parameter, confirmed in stability testing and an archival sample. Potential effects: possible lack of treatment efficacy or unpredictable adverse reactions.

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Risk Level

Medium

Manufacturer

Warszawskie Zakłady Farmaceutyczne POLFA S.A.

Batch Number

01UI0319

Notice Date

25.06.2020

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 Dicortineff with the listed batch numbers, check the batch number on the packaging, and if you have the medicine, return it to the pharmacy or consult a doctor.

Actions Taken

The batch of the medicinal product Dicortineff was withdrawn from the market throughout the country, the decision was given immediate enforceability, and the marketing authorisation holder was obliged...

Need Help?

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

Dicortineff

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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