Sodium Chloride Eye Drops

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

Source: PSNC

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