Dexamytrex

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Unidentified microbiological contamination of the active substance (gentamicin sulfate) may have negative effects on the efficacy and safety of using the eye ointment and constitutes a real and direct risk for patients using the product. Potential effects: eye infections, lack of treatment efficacy, inflammatory complications or damage to ocular tissues.

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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 Dexamytrex ointment from batches 153 and 243; check the batch number on the packaging and, if you have the product, return it to the pharmacy and consult a doctor if the medicine has been u...

Actions Taken

Withdrawal from the market throughout the country of Dexamytrex batches 153 and 243 and a ban on placing these batches on the market; the decision was given 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

Recommendations

Actions Taken

Need Help?

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