| TGA Action ID |
RC-2023-RN-00295-1 |
| Type of Product |
Medicine |
| Product Name/Description |
PSR 18 F DCFPyL
Batch Number.: 2670-0624
Date of Manufacture: 30/03/2023
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 is a radiopharmaceutical manufacturing facility operating under GMP license number, MI-2015-LI-10055-1.
Cyclotek Queensland Pty Ltd is notifying of a reported defective product (cracked vial), supplied to a site on 30th of March 2023. Upon notification of the cracked vial, Cyclotek advised the customer to quarantine the product and return to Cyclotek.
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 |
Upon detection of the cracked vial, the hospital was advised not to use product and to return the cracked vial to Cyclotek
This action has been closed out on 06/03/2024 |
| Action Commencement Date |
3/04/2023 |
| Responsible Entity |
|
| Contact Information |
Cyclotek Queensland - 07 3391 1077 |