| TGA Action ID |
RC-2024-RN-00255-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Compounded Medicines
Multiple Products and Batch numbers
ARTG not on the register |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Baxter Healthcare Compounding Services has initiated this recall action of the compounded products listed below prior to notifying the Therapeutic Goods Administration (TGA) due to the nature of the problem.
Compounded medicines requiring refrigerated storage at (2-8°C) were exposed to room temperature (<25°C) for a period of 4-12hrs.
Prolonged exposure to temperatures outside the labelled shelf life has the potential to adversely impact the quality of the compounded medicine. Available data has been summarised and provided to impacted customers.
This was an isolated event related to batches produced during a single production shift. |
| Instructions for Customers/Users |
If any impacted batches are still available, customers are to return them via the sponsor's courier.
Baxter advises clinicians to evaluate whether there has been any clinical impact to patients who have been administered impacted compounded medicines and monitor for any adverse events or intervention required and report these to Baxter immediately via their Baxter compounding contact.
This action has been closed out on 07/10/2025. |
| Action Commencement Date |
3/04/2024 |
| Responsible Entity |
|
| Contact Information |
0434 390 344 - Evan Francis |