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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.

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