Krople uspokajające spokojne

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

the tested sample of the medicinal product Krople uspokajające spokojne did not meet the requirements specified in the product documentation for total aerobic microbial count (TAMC). This quality defect may pose a potential risk to the health or life of patients. Potential effects: infections, complications, health risk.

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Risk Level

High

Manufacturer

Przedsiębiorstwo Produkcji Farmaceutycznej "GEMI", Grzegorz Nowakowski

Batch Number

011219

Notice Date

12.08.2020

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 product from batch 011219, check the batch number, and return any packages held to a pharmacy. If any alarming symptoms occur after using the product, contact a doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 011219 of the product from the market throughout the country and granted the decision immediate enforceability; the marketing authorisation holder was...

Need Help?

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

Krople uspokajające spokojne

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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