The French national medicinal cannabis trial has got off to a bumpy start after the National Medicines Safety Agency (ANSM) issued a batch recall following “several incident reports” of a quality defect in Tilray’s oral solution THC10 CBD10 product.
The defect related to a leak at the level of the bottle stopper.
Medipha, operator of the drug for Tilray, is recalling the affected batches which have been quarantined pending the recall.
ANSM stressed no vial was issued to any patient but doctors and pharmacists participating in the experiment have been informed they should no longer prescribe or dispense the affected batches.
It said other drugs available for the trial would ensure it could continue and that patients’ needs are met.
Cannabiz understands Little Green Pharma, the back-up supplier for the affected product, will take over, in partnership with French pharmaceutical company Intsel Chimos, until Tilray has resolved the issue.
Cannabiz has approached Tilray for comment.