Syldenafilu cytrynian

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 was found that packaging may be incorrectly labelled, including substance name, batch number and expiry date, which can lead to using the wrong raw material in compounded medicines or using it after the period guaranteeing its efficacy and safety. Potential effects: lack of treatment efficacy, adverse reactions or complications due to use of an incorrect active substance.

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Syldenafilu cytrynian
Risk Level
High
Manufacturer
Fagron sp. z.o.o., ul. Pasternik 26, 31-354 Kraków
Batch Number
229953, 229655, 231874, 229656
Notice Date
19.12.2023
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 indicated batches of Sildenafil citrate raw material in the pharmacy, segregate them from other packs and return them to the wholesaler or marketing authorisation holder; if there are d...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Sildenafil citrate raw material from the market throughout the country, prohibited their placing on the market and granted the deci...

Need Help?

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

Related

Other Notices