CALCIUM POLFARMEX (O SMAKU TRUSKAWKOWYM)

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A quality defect of the medicinal product was found in the form of an improper smell of the syrup, which may indicate irregularities in the composition or stability of the product. Potential effects: lack of efficacy, possible irritation or other adverse reactions.

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CALCIUM POLFARMEX (O SMAKU TRUSKAWKOWYM)

Risk Level

Medium

Manufacturer

Polfarmex S.A.

Notice Date

13.06.2019

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 CALCIUM POLFARMEX syrup from the defective batch, check the batch number on the packaging and, if you have the product, return it to the pharmacy or manufacturer; if adverse effects occur, ...

Actions Taken

The Chief Pharmaceutical Inspector, at the request of the marketing authorisation holder, decided to withdraw the indicated batch of the medicinal product CALCIUM POLFARMEX from the market throughout ...

Need Help?

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

CALCIUM POLFARMEX (O SMAKU TRUSKAWKOWYM)

What to do if you have this product?

What You Should Know

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Actions Taken

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