Zerbaxa

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Microbiological contamination was detected in batches of Zerbaxa, indicating a quality defect that may pose a real risk to patients’ health or life. Potential effects: infection, sepsis, treatment complications, lack of therapeutic efficacy.

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Risk Level

High

Manufacturer

Merck Sharp & Dohme B.V., Holandia

Batch Number

T024608

Notice Date

16.12.2020

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 the medicine from batches T024608 and T025187. Check the batch number on the pack; if you have it, return the product to a pharmacy and consult a doctor if in doubt.

Actions Taken

The Chief Pharmaceutical Inspector withdrew Zerbaxa batches T024608 and T025187 from the entire Polish market and granted the decision immediate enforceability in connection with the global recall.

Need Help?

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

Zerbaxa

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