PCCA Limited has issued a recall for its Ketamine 50mg/5ml and 100mg/5ml oral solutions after a small number of bottles have been observed to contain crystalline material.
The company said it is recalling impacted batches from patients, pharmacies and hospitals as a precautionary measure.
“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,” the MHRA said in an alert.
Affected batches:
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
Remaining stock of the above batches should be quarantined and returned to the company directly.
MHRA asked healthcare professionals who have dispensed the product to contact patients directly to return any impacted products, adding that arrangements will be considered by the company for replacement stock using alternative formulations, where appropriate.
For enquiries, contact the company via email: [email protected]
