Company led medicines recall: PCCA Limited, Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution (unlicensed medicines), CLMR (22)A/04

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.

CLMR Number: CLMR(22)A/04

MDR Number: MDR 044-06/22

Company name: PCCA Limited

 

Details of the affected batches:

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

 

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

Brief description of problem:

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.

Advice to Healthcare Professionals:

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.

Advice to Patients:

Patients who have been dispensed will be contacted directly by their healthcare professional in relation to this issue. If there are any additional concerns about this medicine, please contact your healthcare professional in the first instance.

Company contacts for further information:

For medical information enquiries, please contact: Email: technicaluk@pccarx.com

For stock information enquiries, please contact: Email: purchasing@pccarx.co.uk