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
Product description
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 | 14-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-Apr-2022 |
| 18640-22 | 17-August-2022 | 100ml | 19-May-2022 |
Active ingredient: Ketamine Hydrochloride
Brief description of the 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.
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.
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 Contact for medical information enquiries
For medical information enquiries, please contact:
Email: [email protected]
Company Contact for stock enquiries
For stock information enquiries, please contact:
Email: [email protected]