Autostrzykawka Morfina Przeciwko Bólowi

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.

A problem with solution color was identified: in 4 of 92 auto-injectors the liquid was light green or green instead of colorless or pale yellow, linked to a decrease in the excipient sodium metabisulfite in batch 151021A. Potential effects: possible reduced efficacy and safety of treatment, unpredictable drug action.

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Risk Level

Critical

Manufacturer

Zakład Produkcji Sprzętu Medycznego RAVIMED sp. z o.o. z siedzibą w miejscowości Łajski

Batch Number

151021A

Notice Date

15.12.2023

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 auto-injectors from batch 151021A; if in possession, return the product to the marketing authorization holder or the issuing unit, and consult a doctor if in doubt.

Actions Taken

Marketing of the product was suspended nationwide, tests and an inspection were carried out, a quality defect was confirmed in batch 151021A, this batch was withdrawn from the market, and the decision...

Need Help?

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

Autostrzykawka Morfina Przeciwko Bólowi

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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