Other safety alerts
|
| |
| The United Kingdom: Class 4 Medicines Defect Information: Omega Pharma Limited, Niquitin 14mg Clear Patch |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Omega Pharma Limited has identified an error relating to the product packaging of Niquitin 14mg Clear Patch (nicotine) (batch number: 0370102 and 1110101).
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, Patient Information Leaflet and Summaries of Product Characteristics are correct. There is no issue with the product quality and the batch is not being recalled.
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. 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-omega-pharma-limited-niquitin-14mg-clear-patch-14-patches-el-22-a-slash-32
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Jul 21, 2022
Issued at HKT 14:00
|
| |
