Tranexamic acid injection BP

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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: the ampoule cannot be opened normally, it crumbles, and it is uncertain whether glass fragments have entered the inside and contaminated the solution, creating a risk of administering a medicinal product containing glass to the patient. Potential effects: poisoning, tissue damage, life-threatening complications.

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Risk Level

Critical

Manufacturer

Jackson Laboratories Pvt. Ltd., Indie, podmiot, który uzyskał zgodę Ministra Zdrowia na czasowe dopuszczenie do obrotu produktu leczniczego: Urtica sp. z o.o. Łódź, ul. Kinga C. Gillette 1, 94-406 Łódź,

Batch Number

I-11186

Notice Date

01.09.2023

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 product from batch I-11186, check the batch number on the packaging and return the product to a pharmacy or wholesaler. If the medicine from this batch has been administered and any worryin...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch I-11186 of the medicinal product from the market throughout the country and granted the decision immediate enforceability, obliging the company to car...

Need Help?

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

Tranexamic acid injection BP

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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