Flegafortan

Q: Is this product safe to consume?

No. This product has been recalled due to: It was found that the patient leaflet regarding recommended dosing was inconsistent with the Summary of Product Characteristics, which could lead to incorrect use of the product and overdose manifested by unintended increased volume of bronchial secretions. Potential effects: overdose, increased bronchial secretion, respiratory complications.

It was found that the patient leaflet regarding recommended dosing was inconsistent with the Summary of Product Characteristics, which could lead to incorrect use of the product and overdose manifested by unintended increased volume of bronchial secretions. Potential effects: overdose, increased bronchial secretion, respiratory complications.

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Risk Level

High

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Batch Number

0131G

EAN Code

05909991358150

Recall Date

14.02.2020

What You Should Know

Recommendations

Patients should use Flegafortan in accordance with the current leaflet and the recommendations of a doctor or pharmacist; in case of any doubts about dosing, they should consult a healthcare professio...

Actions Taken

The decision to withdraw batch 0131G of Flegafortan 1.6 mg/ml, syrup from the national market was revoked after the leaflet was updated and correct repackaging in line with Good Manufacturing Practice...

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: It was found that the patient leaflet regarding recommended dosing was inconsistent with the Summary of Product Characteristics, which could lead to incorrect use of the product and overdose manifested by unintended increased volume of bronchial secretions. Potential effects: overdose, increased bronchial secretion, respiratory complications.

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: 0131G

Flegafortan

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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