| TGA Action ID |
RC-2020-RN-00760-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Neurolite Cold Kit
Dose number (Rx) 768773
ARTG 73014
(NEUROLITE bicisate dihydrochloride 0.9mg/mL kit for the preparation of technetium [99Tc] bicisate injection
vial composite pack) |
| ARTG Number |
73014 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Global Medical Solutions Australia has recalled one Neurolite cold kit following the incorrect dispensing of an order that requested one LLK cold kit. The recall resulted from the incorrect filling of the order, where the incorrect cold kit (Neurolite) was supplied, despite batch documentation indicating that the product to be dispensed was LLK. The incorrect cold kit was not used by the customer. No additional products or patients have been impacted by this event.
Global Medical Solutions is investigating the root cause of this issue. |
| Instructions for Customers/Users |
Global Medical Solutions has confirmed that the incorrectly supplied cold kit was not administered to the patient, and advised the customer to dispose of the incorrect kit.
Due to the short lifetime of the product, this action was undertaken prior to TGA notification (Immediate recall action as defined within the Uniform Recall Procedure for Therapeutic Goods).
This action has been closed out on 10/12/2020 |
| Action Commencement Date |
26/08/2020 |
| Responsible Entity |
|
| Contact Information |
07 3356 3800 - Kate Fitzgerald, GMS Australia |