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The drug agency is warning about a recall of Nicopass mint freshness 2.5 mg sugar-free lozenges. They were mistakenly packaged in boxes intended for Nicopass eucalyptus 1.5 mg sugar-free. However, they contain excipients (soya), which can expose patients to an allergic risk.
Nicopass is a non-prescription medicine used to help adolescents aged 15 and over and adults quit smoking.
A packaging error that exposes you to a risk of allergy
The French National Agency for the Safety of Medicines (ANSM) has been informed by a hospital center of an anomaly concerning the packaging of a box of Nicopass lozenges. A pack of Nicopass 2.5 mg sugar-free fresh mint was discovered in a box labeled Nicopass 1.5 mg sugar-free eucalyptus 96 lozenges.
After investigation, the laboratory identified an error during the packaging of batch 4N4RH. Boxes of Nicopass 1.5 mg sugar-free eucalyptus were used to package Nicopass fresh mint 2.5 mg strips. The potential risk of nicotine overdose is minimal. On the other hand, the soybean oil used in the composition of Nicopass 2.5 mg sugar-free fresh mint, and not in that of Nicopass 1.5 mg sugar-free eucalyptus, could expose a risk for patients allergic to soy.
Patients should return the affected boxes
The risk of an allergic reaction occurring is low given the very limited number of boxes concerned. To date, no pharmacovigilance cases related to this packaging error have been reported to the laboratory.
The manufacturer, in agreement with the ANSM, is recalling the entire batch no. 4N4RH, consisting of either Nicopass 1.5 mg sugar-free eucalyptus or Nicopass 2.5 mg sugar-free fresh mint, distributed between 06/11/2024 and 07/08/2024.
Patients who have a box of Nicopass at home with the lot number 4N4RH should return it to their pharmacy for replacement.
Practical information for patients
How do I know if my box of Nicopass 1.5 mg sugar-free eucalyptus (96 lozenges) or Nicopass 2.5 mg sugar-free fresh mint (96 lozenges) comes from batch 4N4RH?
The batch number is on the box of your medicine. If a reference other than 4N4RH is written on your box, you are not affected by the recall.
Lot number 4N4RH is written on my box, what should I do?
Return your box to the pharmacy. Your pharmacist will check the batch number of your box and, if necessary, issue you a new box from a compliant batch.