Gliceryna

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It was found that test results for batches of the pharmaceutical raw material GLICERYNA 85% are out of specification for the parameters: aldehydes and sugars, which means failure to meet established quality requirements for a medicinal product. Potential effects: reduced quality of preparations, possible irritation or other adverse reactions.

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Risk Level

Medium

Manufacturer

Zakład Farmaceutyczny AMARA sp. z o.o.

Batch Number

030819C

Notice Date

06.08.2020

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 GLICERYNA 85% raw material from the listed batches. Healthcare entities and pharmacies should immediately withdraw it from use and return it to the supplier; in case of product use and occu...

Actions Taken

The Chief Pharmaceutical Inspector withdrew all specified batches of the pharmaceutical raw material GLICERYNA 85% from the market throughout the country and granted the decision immediate enforceabil...

Need Help?

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

Gliceryna

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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