Elocom

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A risk was identified of placing on the market Elocom 1 mg/g cream packed in outer cartons for the “ointment” dosage form, causing labeling inconsistent with the contents and potentially misleading patients. Potential effects: improper use of the medicine, lack of expected efficacy, skin complications.

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Risk Level

High

Manufacturer

Organon Biosciences S.R.L, Rumunia podmiot odpowiedzialny w kraju eksportu; Medezin Sp. z o.o. zs. w Łodzi, podmiot uprawniony do importu równoległego

Batch Number

W018404, W015307

Notice Date

29.03.2023

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 Elocom 1 mg/g cream or ointment from batches W018404 and W015307 (GTIN 5909991436568); check the batch number on the package and, if you have the product, return it to the pharmacy; in case...

Actions Taken

The Chief Pharmaceutical Inspector withdrew from the market throughout the country the specified batches of Elocom 1 mg/g (cream and ointment) and granted the decision immediate enforceability.

Need Help?

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

Elocom

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

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