Dexamytrex

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Unidentified microbiological contamination of the active substance (gentamicin sulfate) was detected, posing a real and direct risk to patients and potentially adversely affecting the efficacy and safety of use of the eye ointment. Potential effects: eye infections, infectious complications, reduced treatment effectiveness.

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Risk Level

High

Manufacturer

Dr. Gerhard Mann, Chem.-pharm. Fabrik GmbH, z siedzibą w Niemczech

Batch Number

153

Notice Date

19.10.2023

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 ointment from batches 153 and 243. Check the batch number on the packaging and, if you have these batches, return the product to a pharmacy or contact a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew Dexamytrex batches 153 and 243 from the Polish market and prohibited their further marketing, granting the decision immediate enforceability.

Need Help?

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

Dexamytrex

What to do if you have this product?

What You Should Know

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Actions Taken

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