MHRA: Errors on batches of valproate packs
The Medicines and Healthcare products Regulatory Agency has warned healthcare professionals that some batches of Syonell 250mg and 500mg gastro-resistant tablets contain errors in the product packaging information.
Lupin Healthcare (UK) Limited has informed the MHRA that the outer packaging of the affected batches displays the wrong amount of valproate semisodium, the active pharmaceutical ingredient.
The labelling on the 250mg batches reads 'Syonell 250mg Gastro-Resistant Tablets each gastro-resistant tablet contains 250mg of valproate semi sodium' when it should read 'Syonell 250mg Gastro-Resistant Tablets each gastro-resistant tablet contains 269.06mg of valproate semisodium equivalent to 250mg of valproic acid'.
On the 500mg batches it reads 'Syonell 500mg Gastro-Resistant Tablets each gastro-resistant tablet contains 500mg of valproate semi sodium' when it should read 'Syonell 500mg Gastro-Resistant Tablets each gastro-resistant tablet contains 538.12mg of valproate semisodium equivalent to 500mg of valproic acid'.
“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,” the PSNC said.
The affected 250mg batches are G908002, G908614, G908561, G003139, G003899, G003900 and G003901.
The affected 500mg batches are G908002, G908441, G908835, G000647, G000648, G002361, G002362, G002363, G002901, G004160, G004161, G004168, G004169, G004170, G004171 and G004931.
Batches G004456 and G004457 (250mg) and G004936, G004938, G004940, G004941, G004932 and G004933 (500mg) have been packed and are awaiting distribution.