Sulfarinol

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An out-of-specification result was obtained in stability testing for batch 020618 concerning the parameter “naphazoline nitrate contamination – other single impurity”, with the possibility that this quality defect may occur in other batches still on the market. Potential effects: nasal mucosa irritation, adverse reactions or reduced treatment effectiveness.

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Risk Level

Medium

Manufacturer

Farmaceutyczno-Chemiczna Spółdzielnia Pracy „GALENUS"

Batch Number

231018

Notice Date

15.05.2020

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 Sulfarinol nasal drops from the listed batches, check the batch numbers on the packaging and, if you have the product, return it to the pharmacy or consult a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector withdrew all specified batches of the medicinal product Sulfarinol from the market throughout the country and granted the decision immediate enforceability; the mark...

Need Help?

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

Sulfarinol

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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