Sulfarinol

Q: Is this product safe to consume?

No. This product has been recalled due to: 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.

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

EAN Code

05909990332113

Recall Date

15.05.2020

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.

FAQ

Frequently Asked Questions

Is this product safe to consume?

No. This product has been recalled due to: 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.

What should I do if I already bought this?

Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.

Which batches are affected?

Affected batch numbers: 231018

Sulfarinol

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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