A spray sold to delay ejaculation has been recalled after its manufacturer revealed it was not authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The EXS Delay Spray Plus contains lidocaine, a local anaesthetic.
But the product has not undergone the appropriate assessments related to safety, quality and efficacy, the MHRA said today.
It has recalled the spray 'as a precautionary measure' after the manufacturer, LTC Healthcare, informed the regulator that it was selling a medicinal product containing lidocaine without MHRA authorisation.
The MHRA has instructed pharmacies to stop supplying batches DS29011024 and DS24081023 of the product 'immediately', to quarantine all remaining stock and to liaise with LTC Healthcare about returning it.
Patients have also been advised to stop using the product 'immediately', and to contact the company they purchased from for details of their return process.
The MHRA added: 'Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions and any suspected defects should also be reported via the MHRA Yellow Card scheme.'
And it noted that LTC Healthcare was conducting an ongoing investigation into the issue.
On its website, LTC Healthcare is described as 'a preferred supplier to the NHS' that holds 'numerous contracts across the UK'.
Its products also include own-brand and private-label condoms and lubricants, which it says will 'meet the strict regulatory requirements' for the product's target market.
Concerns have previously been raised about the impact of a rising number of patient safety incidents and medicines recalls on pharmacy teams' workload.
Have your say
Please add your comment in the box below. You can include links, but HTML is not permitted. Please note that comments are not moderated before publication and the views expressed are those of the user and do not reflect the views of The Pharmacist. Remember that submission of comments is governed by our Terms and Conditions. You can also read our full guidelines on article comments here – but please be aware that you are legally liable for any libellous or offensive comments that you make. If you have a complaint about a comment or are concerned that a comment breaches our terms and conditions, please use the ‘Report this comment’ function to alert our web team.