Company led medicines recall: Ketamine 50mg/5ml and 100mg/5ml oral solutions (PCCA Limited)

CLMR number: CLMR (22)A/04

Date issued: 15th June 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for: Ketamine 50mg/5ml and 100mg/5ml oral solutions (PCCA Limited) (unlicensed medicines)

Ketamine 50mg in 5ml Oral Solution (unlicensed medicine)

Batch number Expiry Date Pack Size First Distributed
15806-75 07-July-2022 300ml 08-April-2022
15806-76 18-July-2022 200ml 19-April-2022
15806-77 07-August-2022 100ml 09-May-2022
15806-78 14-August-2022 200ml 16-May-2022
15806-79  4-August-2022 200ml 16-May-2022
15806-80 17-August-2022 100ml 19-May-2022

Ketamine 100mg in 5ml Oral Solution (unlicensed medicine)

Batch number Expiry Date Pack Size First Distributed
18640-20 26-June-2022 100ml 28-Mar-2022
18640-21 24-July-2022 100ml 25-April-2022
18640-22 17-August-2022 100ml 19-May-2022

Active ingredient: Ketamine Hydrochloride

PCCA Limited have been made aware of an issue with the appearance of Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution. A small number of bottles have been observed to contain crystalline material. As a precautionary measure the impacted batches are being recalled from patients, pharmacies and hospitals.

This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers and the company has traceability of the onward distribution by their customers to patients directly.

Remaining stock of the above batches should be quarantined and returned to the company directly.

Healthcare professionals who have dispensed this product, should contact patients directly to return any impacted products. Arrangements will be considered by the company for replacement stock using alternative formulations, where appropriate.

Company Contact for medical information enquiries

For medical information enquiries, please contact:

Email: technicaluk@pccarx.com

Company Contact for stock enquiries

For stock information enquiries, please contact:

Email: purchasing@pccarx.co.uk

To view the alert please visit the GOV.UK website.