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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A possible increased level of impurity E was identified in batches manufactured using glass bottles from one of the suppliers, which constitutes a quality defect of the medicinal product. Potential effects: possible adverse reactions or reduced treatment safety.

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Risk Level

Critical

Manufacturer

Berlin-Chemie AG, Niemcy

Batch Number

73027, 73028, 73029, 81008, 83015, 83020C

Notice Date

05.11.2019

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 syrup from the listed batches. Check the batch number on the packaging and, if you have the product, return it to a pharmacy or consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Flavamed from the market nationwide and granted the decision immediate enforceability, obliging the marketing authorisation holder ...

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?

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