Cernevit

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An abnormal color of the solution after preparation was found, which may result from leaks caused by scratches on vial necks and lead to increased organic impurities or degradation products exceeding toxicological qualifications. Potential effects: toxic drug effects, parenteral complications, risk to patient health.

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Risk Level

Critical

Manufacturer

Baxter Polska Sp.z.o.o

Batch Number

LE22V049

Notice Date

29.11.2022

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 the product from batch LE22V049. Check the batch number and return any packs held to a pharmacy or hospital. If the product has been administered to a patient, consult a physician.

Actions Taken

Withdrawal from the market throughout the entire country of batch LE22V049 of Cernevit, granting the decision immediate enforceability, and obliging the marketing authorization holder to carry out rec...

Need Help?

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

Cernevit

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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