The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for Lupin’s Simvador 10mg, 20mg and 40mg tablets.
Lupin Healthcare (UK) Limited has informed the regulator that the affected batches listed in a table below and also distributed by Discovery Pharmaceuticals/Dexcel Pharma Limited have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
There are no concerns with the quality, safety and efficacy of the product.
However, these affected batches are being recalled due to concerns around the omission of the safety information.
Healthcare professionals have been asked to immediately stop supplying the affected batches and quarantine all remaining stock and return it to their supplier.
Afftected batches of Simvador 10mg, 20mg and 40mg tablets from Lupin Healthcare (UK) Limited are as follows:
|Product||Batch Number||Expiry Date||Pack Size||First Distributed|
|Simvador 10mg tablets||G902211||January 2022||28||07 January 2020|
|Simvador 20mg tablets||G902283||January 2022||28||29 October 2019|
|Simvador 40mg tablets||G803251||February 2021||28||27 July 2018|
|Simvador 40mg tablets||G803252||February 2021||28||27 July 2018|
|Simvador 40mg tablets||G803353||February 2021||28||27 July 2018|
|Simvador 40mg tablets||G803254||February 2021||28||27 July 2018|
|Simvador 40mg tablets||G802355||February 2021||28||27 July 2018|
|Simvador 40mg tablets||G902245||January 2022||28||14 November 2019|
|Simvador 40mg tablets||G902242||January 2022||28||19 November 2019|
|Simvador 40mg tablets||G902243||January 2022||28||30 December 2019|
|Simvador 40mg tablets||G902241||January 2022||28||29 January 2020|