empty

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.

Latest discussions

  1. Pre reg exams

    Thanks for your comments both - Richard ...

  2. Pre reg exams

    Having been qualified just over 40 years...




This website is for healthcare professionals, people who work in pharmacy and pharmacy students. By clicking into any content, you confirm this describes you and that you agree to Pharmacy Magazine's Terms of Use and Privacy Policy.

We use essential, performance, functional and advertising cookies to give you a better web experience. Find out how to manage these cookies here. We also use Interest Based Advertising Cookies to display relevant advertisements on this and other websites based on your viewing behaviour. By clicking "Accept" you agree to the use of these Cookies and our Cookie Policy.