Sumilar HCT

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Capsules with an abnormal appearance and colour were identified inside the blister, which constitutes a suspected quality defect of the medicinal product and a potential risk to patients’ health or life. Potential effects: lack of certainty regarding treatment efficacy and safety.

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Risk Level

Medium

Manufacturer

Sandoz GmbH

Batch Number

12574261

Notice Date

02.05.2022

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 Sumilar HCT from batch 12574261; if you have this product, return the package to a pharmacy and consult a doctor or pharmacist if in doubt.

Actions Taken

Batch 12574261 of the medicinal product Sumilar HCT was suspended from the market nationwide until clarification of the suspected quality defect, and the decision was given immediate enforceability.

Need Help?

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

Sumilar HCT

What to do if you have this product?

What You Should Know

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Actions Taken

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