Flegafortan

Q: Is this product safe to consume?

No. This product has been recalled due to: The patient leaflet regarding recommended dosing was inconsistent with the approved Summary of Product Characteristics, which could lead to incorrect use and overdose manifested by increased volume of bronchial secretions. Potential effects: overdose, worsening cough and adverse drug reactions.

Q: Which batches are affected?

Affected batch numbers: 0129G, 0130G

The patient leaflet regarding recommended dosing was inconsistent with the approved Summary of Product Characteristics, which could lead to incorrect use and overdose manifested by increased volume of bronchial secretions. Potential effects: overdose, worsening cough and adverse drug reactions.

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Risk Level

High

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Batch Number

0129G, 0130G

EAN Code

05909991358150

Recall Date

27.01.2020

What You Should Know

Recommendations

Use the medicine only in accordance with the updated leaflet and the recommendations of your doctor or pharmacist; if you have any doubts about dosing or leaflet content, consult a pharmacist or docto...

Actions Taken

The Chief Pharmaceutical Inspector revoked the decision to withdraw from the market nationwide Flegafortan 1.6 mg/ml, syrup, batches 0129G and 0130G after leaflet correction and confirmation that repa...

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: The patient leaflet regarding recommended dosing was inconsistent with the approved Summary of Product Characteristics, which could lead to incorrect use and overdose manifested by increased volume of bronchial secretions. Potential effects: overdose, worsening cough and adverse drug reactions.

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: 0129G, 0130G

Flegafortan

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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