| TGA Action ID |
RC-2025-RN-00038-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cyanokit 5g powder for solution for infusion
Batch: 2404
Expiry Date: JAN 2027
Supplied via SAS |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
SERB Pharmaceuticals (global product owner) were notified by the manufacturing site of the failure of a routine, biannual media fill for Cyanokit 5 g powder for solution for infusion (hydroxocobalamin).
Two (2) contaminated vials were detected from a total of 2352 filled. The contaminants identified included the objectionable species Enteroccocus faecalis.
UPDATE: 4/3/2025: This action has been updated to a recall of product. |
| Instructions for Customers/Users |
Update 4/3/2025: Customers should:
1. Quarantine stock until product is retrieved by Symbion SAS and credited accordingly.
2. Customers can source a comparative alternative product in the market by searching the Australian Register of Therapeutic Goods (ARTG) under the ingredient name of 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 finalised on 11/9/2025. |
| Action Commencement Date |
29/01/2025 |
| Responsible Entity |
|
| Contact Information |
info@clinect.com.au |