Company led medicines recall: Leeds Trading Company LTC Ltd

Company led medicines recall: Leeds Trading Company LTC Ltd T/A LTC Healthcare, EXS Delay Spray Plus, CLMR(24)A/01

LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA.

CLMR Number: CLMR (24)A/01

DMRC/MDR Number: DMRC-33805417

Company name: Leeds Trading Company LTC Ltd T/A LTC Healthcare

Product description: EXS Delay Spray Plus

Details of the affected batches: 

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 company’s investigation is on-going and all remaining stock of the product should be returned to the company directly.

Advice to 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 to 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 the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information enquiries, please contact Andy Taylor, Managing Director:

Email: andy@ltchealthcare.co.uk Telephone: 01423 326687

For stock information enquiries, please contact Andy Taylor, Managing Director:

Email: andy@ltchealthcare.co.uk Telephone: 01423 326687