Vesomni Tablets Defect Notification - Incorrect Barcode

MHRA Guidance & Safety

Published March 26th, 2026

Detected March 26th, 2026

Summary

The MHRA issued a Class 4 Medicines Defect Notification regarding Quadrant Pharmaceuticals Limited's Vesomni 6 mg/0.4 mg modified release tablets. The parallel imported packs have an incorrect barcode/GTIN on the carton, but the product quality is unaffected. No recall is issued, and patients do not need to take action.

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What changed

Quadrant Pharmaceuticals Limited has notified the MHRA of a labelling defect on specific batches of parallel imported Vesomni 6 mg/0.4 mg modified release tablets. The affected cartons bear an incorrect barcode/GTIN, which belongs to a different product (Solaraze 3% Gel). Crucially, the medicine's name, strength, and pharmaceutical form are correctly stated on the carton, and the quality of the tablets themselves is not compromised.

Due to the nature of the defect (incorrect barcode only, no impact on product quality), this is classified as a Class 4 Medicines Defect Notification, and no recall has been initiated. Healthcare professionals are advised not to use these batches in robotic or automated dispensing systems and to perform manual dispensing and stocking. Patients are instructed that no action is required from them, and they should continue to take their medication as prescribed. Any adverse reactions should be reported via the MHRA Yellow Card scheme.

What to do next

Do not use affected batches in robotic or automated dispensing systems.
Carry out manual dispensing and stocking for affected batches.
Inform patients that no action is required from them.

Source document (simplified)

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

From: Medicines and Healthcare products Regulatory Agency Published 26 March 2026 Message type: Medicines recall/notification Medical specialty: Dispensing GP practices and Pharmacy Issued: 26 March 2026

DMRC reference number

DMRC-38793027

Marketing Authorisation Holder

Quadrant Pharmaceuticals Limited

Medicine Details

Vesomni 6 mg/0.4 mg modified release tablets

PLPI: 20774/2577

Active Ingredient: solifenacin succinate, tamsulosin hydrochloride

SNOMED code: 11980501000001100

GTIN: 5061052110579

Affected Lot Batch Numbers

| Batch No. | Expiry Date | Pack Size | First Distributed |
| --- | --- | --- | --- |
| 4097Y | 31/12/2026 | 30 tablets | 31/12/2025 |
| 4105Y | 30/09/2026 | 30 tablets | 31/12/2025 |
| 4322Y | 31/12/2026 | 30 tablets | 31/12/2025 |
| 5386Y | 31/12/2026 | 30 tablets | 05/01/2026 |
| 7330Y | 31/12/2026 | 30 tablets | 06/02/2026 |
| 7347Y | 30/04/2027 | 30 tablets | 12/02/2026 |

Background

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 for 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 for Healthcare Professionals to Provide 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.

Additional 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.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre

10 South Colonnade

Canary Wharf

London

E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk