Class 4

Class 4 Medicines Defect Information: Omega Pharma Limited, Niquitin 14mg Clear Patch (14 patches), EL(22)A/32

Omega Pharma Limited have identified an error relating to the product packaging.

MDR Number: MDR 041-07/22

Company name: Omega Pharma Limited

Product description: Niquitin 14mg Clear Patch PL 02855/0251

Details of the affected batch:

Batch Number

Expiry Date

Pack Size

First Distributed

0370102

Aug-2024

14 patches

08-Jun-2022

1110101

Mar-2025

14 patches

Not Distributed Yet

Active Pharmaceutical Ingredient: Nicotine

Brief description of problem:

Omega Pharma Limited have identified an error relating to the product packaging. In the ‘Ingredients’ section on the base of the carton, the patch dosage is stated as providing 21mg of nicotine per day. The correct dosage is 14mg per day. The other dosage indications on the carton, the sachets, PIL and SmPC are correct. There is no issue with the product quality and the batch is not being recalled.

Advice to Healthcare Professionals and retailers:

Healthcare professionals and other retailers are advised to note the error relating to the product packaging and where possible should refer to the dose on the other areas of the carton or sachet which remains correct. As stated above, each patch provides 14mg of nicotine per day and this information should be used when using this product.

Since all batches are within specification and there are no quality issues with the product, the batches on hold awaiting distribution will be sold and have been included in this notification for information. Omega Pharma Limited have confirmed that only these two batches are impacted and all future batches will be packaged with the correct carton.

Advice to Patients:

Patients are advised to note the error relating to the product packaging and are not required to take any further action at this time. The medicine itself is not affected and each patch provides 14mg of nicotine per day. If you have concerns about a medicine you may be using, please contact your healthcare professional.

 

Company contacts for further information:

For medical information and stock control queries please contact: uklocustomerservice@perrigo.com

To access the full recall:

Class 4 Medicines Defect Information: Omega Pharma Limited, Niquitin 14mg Clear Patch (14 patches), EL(22)A/32