| TGA Action ID |
RC-2025-RN-00036-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cyanokit 5g powder for solution for infusion
Batch number: 2404
Manufacture date: 01 February 2024
Expiry date: 25 January 2027
Supplied via SAS |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
A sterility assurance problem was identified during routine manufacturing quality control. There is a potential risk of microbial contamination (Enterococcus faecalis) in certain batches, including Batch 2404.
Although the risk of contamination is considered low, it cannot be completely excluded. Intravenous administration of a contaminated product may pose a risk of systemic infection or sepsis, particularly in immunocompromised patients.
To date no adverse events have been reported in relation to this problem.
UPDATE: 4/3/2025: This action has been updated to a recall of product. |
| Instructions for Customers/Users |
UPDATE 4/3/25:
Customers are to:
- Cease use of affected stock and quarantine.
- Pack and prepare affected stock for collection as per the customer letter.
- A shipping return label will be provided once the customer response form is received confirming quantity of affected stock.
Customers seeking a comparable alternative product may search the Australian Register of Therapeutic Goods (ARTG) under the ingredient name sodium thiosulfate pentahydrate. Clinicians are advised to consult best practice guidelines and the product information when administering the product to ensure its correct use, which may include the need for another medicine to use alongside it.
This action has been closed out on 04/06/2026 |
| Action Commencement Date |
29/01/2025 |
| Responsible Entity |
|
| Contact Information |
1300 077 674 - Pro Pharmaceuticals |