Enema

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.

Sediment in bottles in the form of solid white particles and turbidity of the solution not meeting product specification. Potential effects: reduced efficacy, irritation, impaired product quality.

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Risk Level

Medium

Manufacturer

Laboratorium Galenowe Olsztyn sp. z o.o. z siedzibą w Dywity

Batch Number

08224

Notice Date

14.11.2024

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 products from batches 08224 and 08324. Check the batch number and return the product to the pharmacy or marketing authorization holder. If symptoms occur, contact a physician.

Actions Taken

Withdrawal from the market nationwide for batches 08224 and 08324; prohibition of placing on the market; decision immediately enforceable; MAH obliged to act according to regulations (including destru...

Need Help?

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

Enema

What to do if you have this product?

What You Should Know

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Actions Taken

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