| TGA Action ID |
RC-2023-RN-00316-1 |
| Type of Product |
Medicine |
| Product Name/Description |
(18F) DCFPyL
Batch number: 2670-0626
Date of manufacture: 04/04/2023
Product is exempt from the ARTG |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Cyclotek Queensland is notifying of a cracked vial. The customer was advised to quarantine the product and return the affected product to Cyclotek.
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, this action was undertaken prior to TGA notification (Immediate Recall Action as defined within the URPTG). |
| Instructions for Customers/Users |
Upon detection of the cracked vial, the customer was advised to quarantine and return to the manufacturing site.
This action has been closed out on 06/03/2024 |
| Action Commencement Date |
5/04/2023 |
| Responsible Entity |
|
| Contact Information |
Cyclotek Queensland - 07 3391 1077 |