Lidocaine hydrochloride monohydrate, 100 mg/100 mg, 1 g pack

GIF decision: Withdrawal from market, Marketing prohibition

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

In one pack of the pharmaceutical raw material Lidocaine hydrochloride monohydrate a different active substance (hydrocortisone) was found, creating a risk of preparing a medicine with a qualitative composition not compliant with the prescription. Potential effects: lack of treatment efficacy, unintended steroid effects, therapy complications.

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Lidocaine hydrochloride monohydrate, 100 mg/100 mg, 1 g pack

Risk Level

High

Batch Number

003029

Notice Date

03.07.2025

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 the raw material Lidocaine hydrochloride monohydrate from batch 003029. Check the batch number at the pharmacy and return the product to the pharmacy or wholesaler. If in doubt about medici...

Actions Taken

The Chief Pharmaceutical Inspector withdrew batch 003029 of the raw material Lidocaine hydrochloride monohydrate from the entire national market, prohibited its placing on the market, and granted the ...

Need Help?

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

Lidocaine hydrochloride monohydrate, 100 mg/100 mg, 1 g pack

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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