Class 4 Medicines Defect Notification: Vesomni 6 mg/0.4 mg Tablets - Incorrect Barcode
Summary
Quadrant Pharmaceuticals Limited has issued a Class 4 defect notification for six batches of parallel-imported Vesomni 6 mg/0.4 mg modified release tablets (PLPI: 20774/2577) due to an incorrectly printed barcode/GTIN on the carton. The GTIN printed on affected packs (Batch Nos. 4097Y, 4105Y, 4322Y, 5386Y, 7330Y, 7347Y) is that of Solaraze 3% Gel packs containing diclofenac. Product quality of the tablets is not impacted. Affected batches are NOT being recalled. Healthcare professionals should not use these batches in robotic or automated dispensing or stocking systems and should carry out manual dispensing instead. Patients are advised no action is required and they should continue taking their medication as prescribed.
“Do not to use this batch of medicine in robotic or automated dispensing or stocking systems. Carry out manual dispensing and stocking, as appropriate.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
Quadrant Pharmaceuticals Limited has identified that six batches of parallel-imported Vesomni 6 mg/0.4 mg modified release tablets were printed with the incorrect GTIN/barcode on the outer carton. The GTIN on affected packs (Batch Nos. 4097Y, 4105Y, 4322Y, 5386Y, 7330Y, 7347Y) corresponds to Solaraze 3% Gel, not Vesomni. All other product details including name, strength, and pharmaceutical form are correct. Product quality is unaffected.\n\nHealthcare professionals using robotic or automated dispensing or stocking systems should immediately switch to manual dispensing for these specific batches. Dispensing GP practices and community pharmacies should bring this notice to the attention of relevant staff and ensure automated systems are updated or bypassed for affected batch numbers. Patients require no action and should continue their medication as prescribed.
What to do next
- Do not to use this batch of medicine in robotic or automated dispensing or stocking systems. Carry out manual dispensing and stocking, as appropriate.
Archived snapshot
Mar 26, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets , EL(26)A/16
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.
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
Download document
Updates to this page
Published 26 March 2026 Contents
Mentioned entities
Parties
Related changes
Get daily alerts for MHRA Guidance & Safety
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from MHRA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when MHRA Guidance & Safety publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.