Hycamtin

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.

The identified deviation concerns the active substance content. Administration of the medicine with an increased amount of topotecan may negatively affect treatment tolerability; haematological toxic effects are dose-dependent and may pose a health risk to the patient. Potential effects: haematological toxicity, complications of oncological treatment.

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Risk Level

High

Manufacturer

Sandoz Pharmaceuticals d.d., Verovškova ulica 57, 1000 Ljubljana, Slovenia;

Batch Number

BCUN2

Notice Date

02.10.2023

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 Hycamtin (Topotecan) products with batch numbers BCUN2 and BCUN3; if you possess these packs, contact a pharmacist or doctor.

Actions Taken

The Chief Pharmaceutical Inspector prohibited the placement on the market throughout the country of Hycamtin (Topotecan) batches BCUN2 and BCUN3 and granted the decision immediate enforceability.

Need Help?

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

Hycamtin

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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