| TGA Action ID |
RC-2024-RN-00811-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Circle CBD Pure 100 Oil 30ml
Product Code: C0l-Cl00000-030-1
Batches: EFP100S424001, FX-CBD-24002-1, FX-CBD-23362-1
Expiry Date: 06/2025
Supplied via SAS/AP pathways |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
Three batches were incorrectly labelled in their THC content indicating the product contained less than 90mg(<3mg/mL), instead of the correct amount of less than 30mg (<1mg/mL).
The discrepancy between the labelled and actual THC concentrations may confuse patients and pharmacists, as the label incorrectly suggests a higher THC content and a different scheduling category.
The potential hazard for patients is underdosing. Decreasing recommended dosage and not following prescriber instructions could impact the intended effect of the medication, and patients could see decreased or ineffective symptom management as a result. The likelihood of the harm occurring is considered unlikely. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock and quarantine affected batches (EFP1005424001, FX-CBD-24002-1 and FX-CBD-23362-1) on hand to prevent further use.
- Return affected stock on hand with the completed response form to Montu Group.
- Contact the sponsor to organise immediate replacement of stock. |
| Action Commencement Date |
13/09/2024 |
| Responsible Entity |
|
| Contact Information |
03 7003 8214 - Leafio Customer Support |