| TGA Action ID |
RC-2023-RN-00225-1 |
| Type of Product |
Medicine |
| Product Name/Description |
18F Fludeoxyglucose
Batch number: 2210-3502
Date of manufacture: 09/03/2023
Product is exempt from the ARTG |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
On 9th March 2023, Cyclotek QLD was advised of a cracked vial which was received by a customer.
Upon detection of the cracked vial, the customer was advised to quarantine and return the affected product.
Investigations are currently underway as to the root cause of the issue with a number of preventative actions proposed.
Given the nature of the product, the recall was initiated prior to TGA notification (as an Immediate Recall Action following the Uniform Recall Procedure for Therapeutic Goods). |
| Instructions for Customers/Users |
The impacted customer contacted Cyclotek Queensland upon identifying the issue. The defective product was not used, and the vial was returned to the manufacturing site.
This action has been closed out on 06/03/2024 |
| Action Commencement Date |
16/03/2023 |
| Responsible Entity |
|
| Contact Information |
07 3391 1077 - Cyclotek QLD |