Tramal

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 was found consisting of unglued outer packaging of the product, which may affect the safety and correct use of the medicine. Potential effects: possible compromise of packaging integrity, risk of improper use or dosing errors.

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Risk Level

Medium

Manufacturer

STADA Arzneimittel AG, Niemcy

Batch Number

01422PA

Notice Date

10.12.2020

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 Tramal 100 mg/ml from batch 01422PA; if you have it, return it to a pharmacy or consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 01422PA of the medicinal product Tramal 100 mg/ml from the market throughout the country and granted the decision immediate enforceability, obliging t...

Need Help?

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

Tramal

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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