Oekolp forte

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.

An exceedance of the acceptable content of an unknown impurity was found in batch 23000333, making it impossible to assess the safety of the medicine’s use; the authority indicated a real risk to patients’ health and potentially life. Potencjalne skutki: poisoning, unknown adverse reactions, threat to health or life.

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Oekolp forte
Risk Level
Critical
Manufacturer
Besins Healthcare Germany GmbH, Niemcy; importer równoległy: InPharm sp. z o.o., Warszawa
Batch Number
23000333
Notice Date
13.05.2024
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 product from batch 23000333, check the batch number on the packaging and, if you have it, return it to the pharmacy; if it has been used, contact a doctor.

Actions Taken

Withdrawal from the entire national market of batch 23000333 of Oekolp forte, 0.5 mg, pessaries, prohibition of placing this batch on the market, and granting the decision immediate enforceability.

Need Help?

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

Related

Other Notices