Lorabex

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

It was suspected that the product might not meet quality requirements (out-of-specification results for lorazepam content and related substances), but testing of samples taken from the market confirmed correct quality of the batch. Potential effects: possible alteration of drug action, lack of efficacy or adverse effects.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne „POLPHARMA” S.A. z siedzibą w Starogardzie Gdańskim

Batch Number

A905BB

Notice Date

29.06.2023

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

Patients may use the medicine from this batch according to the doctor’s instructions; there is no need to return it or stop using it due to the quality of this batch.

Actions Taken

The Chief Pharmaceutical Inspector declared the expiry of the 16.02.2023 decision suspending the batch from the market, after carrying out additional quality tests on samples taken from the market.

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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