Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets , EL(26)A/16

Primary tabs

Quadrant Pharmaceuticals Limited have informed the MHRA that their parallel imported packs of Vesomni 6 mg/0.4 mg modified release tablets have been printed with the incorrect barcode/GTIN on the carton.

DMRC Number: DMRC-38793027

Company name:Quadrant Pharmaceuticals Limited

Product description: Vesomni 6 mg/0.4 mg modified release tablets

PLPI: 20774/2577

Active Ingredient: solifenacin succinate, tamsulosin hydrochloride

SNOMED code: 11980501000001100

Details of the affected batch:

Batch No.Expiry DatePack SizeFirst Distributed
4097Y31/12/202630 tablets31/12/2025
4105Y30/09/202630 tablets31/12/2025
4322Y31/12/202630 tablets31/12/2025
5386Y31/12/202630 tablets05/01/2026
7330Y31/12/202630 tablets06/02/2026
7347Y30/04/202730 tablets12/02/2026

Background information: 

Quadrant Pharmaceuticals Limited have informed the MHRA that their parallel imported packs of Vesomni 6 mg/0.4 mg modified release tablets have been printed with the incorrect barcode/GTIN on the carton. The GTIN printed on the affected packs is the GTIN for their parallel imported Solaraze 3% Gel 2 x 25 g packs (containing diclofenac). The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The quality of the tablets is not impacted by the labelling defect.

Only the specified batches of imported packs are affected.

Advice to Healthcare Professionals: 

Do not to use this batch of medicine in robotic or automated dispensing or stocking systems. Carry out manual dispensing and stocking, as appropriate. Product quality of the Vesomni 6 mg/0.4 mg modified release tablets is not impacted by this issue, therefore the affected batches are not being recalled.

Advice to Patients: 

No action is needed from patients, continue to take medication from these batches of tablets. The actions will be controlled by the healthcare professionals who prescribe or dispense the medication.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For all medical information enquiries and information on this product, please email maxearnqa@maxearn.co.uk or telephone 01204 471269.

For stock control enquiries please email maxearnqa@maxearn.co.uk or telephone 01204 471269.

To access the full recall/alert: 

Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets , EL(26)A/16