Vesomni 6 mg/0.4 mg modified release tablets
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC-38793027
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Vesomni 6 mg/0.4 mg modified release tablets | solifenacin succinate, tamsulosin hydrochloride | 5061052110579 |
Batches (expiry): 4097Y (31/12/2026), 4105Y (30/09/2026), 4322Y (31/12/2026), 5386Y (31/12/2026), 7330Y (31/12/2026), 7347Y (30/04/2027)
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: