Benlek

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.

The product does not meet the required quality specifications due to a negative result for the parameter “Chromatographic purity of thiamine hydrochloride”, indicating the presence of undesirable impurities. Potential effects: reduced treatment efficacy or unpredictable adverse reactions.

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Risk Level

Medium

Manufacturer

SOLINEA sp. z o.o. sp. k. z siedzibą w Ciecierzynie

Batch Number

0321222

Notice Date

29.09.2023

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 Benlek until the decision is revoked. Check the batch number and return any packs, especially batch 0321222, to the pharmacy and consult a doctor if in doubt.

Actions Taken

The Chief Pharmaceutical Inspector suspended the distribution of the medicinal product Benlek throughout the country and granted the decision immediate enforceability after a negative quality test res...

Need Help?

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

Benlek

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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