Flavamed

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Tests by the National Medicines Institute confirmed that the sample of Flavamed batch 82014 did not meet purity specification requirements due to an exceeded level of impurity E, which makes a potential health risk for patients plausible. Potential effects: possible adverse reactions, complications, reduced treatment safety.

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Risk Level

Medium

Manufacturer

Berlin-Chemie AG, Niemcy

Batch Number

81004, 81007, 82013, 82014, 83018A, 83019A, 83021A

Notice Date

30.10.2019

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 Flavamed syrup from the listed batches; check the batch number on the package and, if you have the product, return it to the pharmacy and consult a doctor if in doubt.

Actions Taken

The specified batches of the medicinal product Flavamed were withdrawn from the market nationwide, the decision was given immediate enforceability, and the marketing authorisation holder was obliged t...

Need Help?

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

Flavamed

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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