| TGA Action ID |
RC-2023-RN-00234-1 |
| Type of Product |
Medicine |
| Product Name/Description |
18F DCFPyL PSR
Batch number: 2670-0617
Date of Manufacture: 14/03/2023
Product is exempt from the ARTG |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Cyclotek Queensland Pty Ltd are advising of a reported defective product (cracked vial).
Upon notification of the cracked vial, Cyclotek advised the customer to quarantine the product and return to Cyclotek as soon as possible. The product was not used and was returned on 14/03/23.
Investigations are currently underway as to the root cause of the issue.
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 |
The customer was advised to quarantine the vial and return to Cyclotek as soon as possible. Vial was received by Cyclotek Queensland on 14/03/23.
This action has been closed out on 06/03/2024 |
| Action Commencement Date |
15/03/2023 |
| Responsible Entity |
|
| Contact Information |
07 3391 1077 - Cyclotek Queensland |