Cann Group has told the ASX one of its customers has commenced a class III recall of 250 units of its 50ml medicinal cannabis oil products.
A class III recall is not safety-related and is undertaken where a deficient product is not likely to cause adverse health consequences.
Cann said 11 units have been supplied to patients with the balance being retained by the customer’s distributor.
The products were manufactured and released by a third-party GMP-licensed manufacturer, engaged by Cann, using ingredients from another third party.
The company said the recall follows the identification of particulate matter in a subsequent batch of the product by Cann’s manufacturer, who notified them of the issue.
It added in a statement: “In line with the Therapeutic Goods Administration’s (TGA) processes, the sponsor of the product in Australia (the customer’s distributor) is liaising with the TGA to coordinate the recall.
“Cann is working with its customer, manufacturer and supplier to identify the cause of the issues in relation to these products.”