Class 4 Medicines Defect Information: Niquitin 14mg Clear Patch – 14 patches (Omega Pharma Limited)

Class 4 Medicines Defect Information:

Niquitin 14mg Clear Patch – 14 patches (Omega Pharma Limited)

Drug alert number: EL (22)A/32

Date issued: 20 July 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Niquitin 14mg Clear Patch PL 02855/0251

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 the 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 for 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.

View full alert here

Further Information

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