Temozolomide Sun

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Stability testing showed that the product does not meet quality specification requirements for active substance content; the content is reduced below the lower acceptance limit, which affects the product’s effectiveness. Potential effects: reduced treatment efficacy, possible lack of therapeutic effect.

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Risk Level

Medium

Manufacturer

Sun Pharmaceutical Industries Europe B.V., z siedzibą w Hoofddorp, Holandia

Batch Number

HAD3165E

Notice Date

09.11.2023

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 the medicine from batch HAD3165E, check the batch number on the packaging and return the product to the pharmacy; if in doubt, contact your treating physician.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch HAD3165E of Temozolomide Sun from the market nationwide, prohibited its further placing on the market and granted the decision immediate enforceabilit...

Need Help?

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

Temozolomide Sun

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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