TRANXENE 20

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 identified: potential presence of visible particles in solvent ampoules of a product intended for preparation of an injectable solution. Potential effects: complications after intravenous administration, embolism, inflammatory reactions, lack of treatment safety.

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Risk Level

Critical

Manufacturer

Sanofi-Aventis France

Batch Number

A7165

Notice Date

23.10.2019

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 Tranxene 20 from batches A7165, A8171 and A8180; if in possession, return it to the pharmacy and consult a doctor in case of any doubts.

Actions Taken

The Chief Pharmaceutical Inspector withdrew Tranxene 20 batches A7165, A8171 and A8180 from the market throughout Poland, granted the decision immediate enforceability, and obliged the marketing autho...

Need Help?

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

TRANXENE 20

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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