PCCA Limited recalls batches of Ketamine oral solutions


Share post:

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]


Please enter your comment!
Please enter your name here

Current Issue June 2023

Related articles

MHRA grants authorisation for LEO Pharma’s Adtralza 2 mL pen solution

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution...

Grundon launches maiden UK-wide inhaler recycling programme

Grundon Waste Management has introduced what it claims to be the UK's first verified nationwide inhaler return and...

‘Record fine imposed on hydrocortisone manufacturers for dominant position abuse and 10,000% price increase’

The Competition Appeal Tribunal (CAT) has upheld the Competition and Markets Authority’s (CMA) findings against two pharmaceutical manufacturers...

Vision Report: Legal reforms, adequate funding imperative for success of community pharmacy

Achieving the community pharmacy vision necessitates legal adjustments and additional funding beyond recent boosts, the pharmacy vision document...