Lorabex

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Suspected quality defect: out-of-specification (OOS) results for the parameters Lorazepam content and Lorazepam related substances, which may indicate an incorrect amount of active substance and impurities in the solution for injection. Potential effects: lack of treatment efficacy, excessive sedative effect, adverse reactions, complications.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne „Polpharma” S.A., ul. Pelplińska 19, 83-200 Starogard Gdańsk

Batch Number

A905BB

Notice Date

16.02.2023

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 the product from batch A905BB; patients who have this medicine should consult a doctor or pharmacist regarding further treatment and possible return of the packs to a pharmacy.

Actions Taken

The distribution of batch A905BB of Lorabex 4 mg/ml, solution for injection, has been suspended throughout the country, with the decision given immediate enforceability; the marketing authorisation ho...

Need Help?

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

Lorabex

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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