Medicines Healthcare Products Regulatory Agency
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CLMR Number
CLMR (24)A/01
DMRC Reference Number
DMRC-33805417
Company name
Leeds Trading Company LTC Ltd T/A LTC Healthcare
EXS Delay Spray Plus
| Product Name | Batch Number | Expiry Date | Pack Size | Date first Distributed |
|---|---|---|---|---|
| EXS Delay Spray Plus | DS29011024 | 01/2027 | 50ml | 04/2024 |
| EXS Delay Spray Plus | DS24081023 | 08/2026 | 50ml | 11/2023 |
Brief Description of Problem
LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA. This recall is to provide information to customers who may use or have used the product and to provide mitigation of any further supply of a product without the appropriate authorisation.
EXS Delay Spray Plus is being sold as a spray to delay ejaculation.
There is limited information on the quantity of lidocaine present in EXS Delay Spray Plus, therefore as a precautionary measure the product is being recalled on safety grounds, noting the product has not undergone the appropriate assessments related to safety, quality and efficacy. The companys investigation is on-going and all remaining stock of the product should be returned to the company directly.
Advice for healthcare professionals, wholesalers and retailers:
- Stop supplying the batches above immediately. Quarantine all remaining stock and liaise with LTC Healthcare on the return process.
- This recall is being issued as a company-led medicines recall as LTC Healthcare has traceability of direct sales and will also contact distributors that have been provided the affected products onwards to customers to initiate recall action.
Advice for patients:
- Stop using the product immediately. Contact the company where you purchased the product from for details of their returns process.
- EXS Delay Spray Plus has not been assessed for quality, safety or efficacy, therefore the released batches are being recalled.
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 theMHRA Yellow Card scheme.
Company Contact for medical information enquiries
For medical information enquiries, please contact Andy Taylor, Managing Director:
Email:andy@ltchealthcare.co.uk
Telephone: 01423 326687
Company Contact for stock enquiries
For stock information enquiries, please contact Andy Taylor, Managing Director:
Email: andy@ltchealthcare.co.uk
Telephone: 01423 326687