Class 4 Medicines Defect Information, Syonell 250mg Gastro-Resistant Tablets,(PL 35507/0191), Syonell 500mg Gastro-Resistant Tablets, (PL 35507/0192), EL (21)A/11
Lupin Healthcare (UK) Limited has informed health and medication authorities 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.
MDR Number
MDR 012-04/21
Company name
Lupin Healthcare (UK)
Product description
Syonell 250mg Gastro-Resistant Tablets
| 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
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| G908022 | 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 | – |
Active Pharmaceutical Ingredient: valproate semisodium
Brief description of the problem
Lupin Healthcare (UK) Limited has informed health and medication authorities 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).
Advice for healthcare professionals
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.
Further information
For more information or medical information queries, please contact: +44 (0) 1565 751 378 Option 1 or Pharmacovigilance Department at EU-PV@lupin.com
For stock control queries, please contact: 44 (0) 1565 751 378 Option 2 or information@lupin.com
Recipients of this Medicines Notification 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.
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