| TGA Action ID |
RC-2025-RN-00079-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cyanokit Hydroxocobalamin 5g powder for solution for infusion
Product code: MRK-CYANO
Batch number: 2404-01
Expiry date: 25 January 2027
Supplied via SAS |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Retail |
| 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). Two (2) contaminated vials were detected from a total of 2352 filled.
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.
-Complete the response for to arrange form return of stock and a credit.
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 finalised on 4/7/2025. |
| Action Commencement Date |
3/02/2025 |
| Responsible Entity |
|
| Contact Information |
sales@sanaxmedical.com.au - Sanax Medical and First Aid Supplies |