The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect alert for Syonell 250mg & 500mg gastro-resistant tablets of Lupin Healthcare (UK) Limited.
Lupin has informed the health regulator of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets.
This discrepancy relates to the incorrect amount of active pharmaceutical ingredient-valproate semisodium printed on the outer packaging.
| Labelling on the current packaging | Correct labelling on the packaging |
| Syonell 250mg Gastro-Resistant Tablets each gastro-resistant tablet contains 250mg of valproate semi sodium | Syonell 250mg Gastro-Resistant Tablets each gastro-resistant tablet contains 269.06mg of valproate semisodium equivalent to 250mg of valproic acid |
| Syonell 500mg Gastro-Resistant Tablets each gastro-resistant tablet contains 500mg of valproate semi sodium | Syonell 500mg Gastro-Resistant Tablets each gastro-resistant tablet contains 538.12mg of valproate semisodium equivalent to 500mg of valproic acid |
The amounts of active pharmaceutical ingredient are stated correctly in the respective Patient Information Leaflets (PIL) and Summary of Product Characteristics (SmPCs).
Syonell 250mg Gastro-Resistant Tablets with PL 35507/0191
| Batch Number | Expiry Date | Pack Size | First Distributed |
| G908002 | Sep – 21 | 30 | 06/01/2020 |
| G908614 | Oct – 21 | 30 | 08/04/2020 |
| G908561 | Oct -21 | 30 | 20/03/2020 |
| G003139 | Mar- 22 | 30 | 18/06/2020 |
| G003899 | Apr- 22 | 30 | 25/09/2020 |
| G003900 | Apr- 22 | 30 | 05/10/2020 |
| G003901 | Apr- 22 | 30 | 04/02/2021 |
The following batches have been packed and are awaiting distribution
| Batch Number | Expiry Date | Pack Size | First Distributed |
| G004456 | May-22 | 30 | – |
| G004457 | May-22 | 30 | – |
Syonell 500mg Gastro-Resistant Tablets PL 35507/0192
| Batch Number | Expiry Date | Pack Size | First Distributed |
| G908002 | Sep – 21 | 30 | 27/12/2019 |
| G908441 | Oct – 21 | 30 | 09/03/2020 |
| G908835 | Oct -21 | 30 | 15/03/2020 |
| G000647 | Dec – 21 | 30 | 20/03/2020 |
| G000648 | Dec – 21 | 30 | 05/04/2020 |
| G002361 | Feb – 22 | 30 | 11/05/2020 |
| G002362 | Feb – 22 | 30 | 12/05/2020 |
| G002363 | Dec- 21 | 30 | 28/05/2020 |
| G002901 | Mar -22 | 30 | 18/06/2020 |
| G004160 | Apr – 22 | 30 | 24/09/2020 |
| G004161 | Apr – 22 | 30 | 27/09/2020 |
| G004168 | Apr – 22 | 30 | 26/10/2020 |
| G004169 | Apr – 22 | 30 | 08/12/2020 |
| G004170 | Apr – 22 | 30 | 01/02/2021 |
| G004171 | Apr – 22 | 30 | 09/03/2021 |
| G004931 | May – 22 | 30 | 11/01/2021 |
The following batches have been packed and are awaiting distribution
| Batch Number | Expiry Date | Pack Size | First Distributed |
| G004936 | May-22 | 30 | – |
| G004938 | May-22 | 30 | – |
| G004940 | May-22 | 30 | – |
| G004941 | May-22 | 30 | – |
| G004932 | May-22 | 30 | – |
| G004933 | May-22 | 30 | – |
The MHRA further added that, the healthcare professionals are advised to exercise caution when dispensing the product. There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled.
