Join the DDA or

Syonell sodium valproate packaging error

Outer packaging has ingredient listing error

May 5th 2021

Tagged: MHRA alert

By MHRA

Lupin Healthcare (UK) Limited has advised 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 packagingCorrect labelling on the packaging
Syonell 250mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 250mg of valproate semi sodiumSyonell 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 sodiumSyonell 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).

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled.