GLICEROL

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Out-of-specification results were found for aldehydes, sugars, impurity A and related substances during stability testing of batch 01916, which makes a potential threat to the quality and safety of the medicinal product plausible. Potential effects: lack of efficacy or unforeseen adverse reactions.

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Risk Level

Medium

Manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o.

Notice Date

14.02.2019

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 product from the batches covered by the decision and return it to the pharmacy or the marketing authorisation holder; if there are any doubts about a taken medicine, consult a doctor or...

Actions Taken

The marketing authorisation holder submitted an application and is preventively withdrawing all specified batches of the medicinal product from the market, and the Chief Pharmaceutical Inspector issue...

Need Help?

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

GLICEROL

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

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