| TGA Action ID |
RC-2023-RN-00521-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Tiger Snake Antivenom 3000 Units Injection Vial
Lot number: 283433
Product Code 10040121
Expiry: 08/2023
ARTG 74895
(TIGER SNAKE ANTIVENOM (equine) 3000U injection vial) |
| ARTG Number |
74895 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
There has been an Out of Specification at 31 months for potency. Administration of a sub-potent antivenom may require larger doses/volumes to be administered which may also increase the risk of adverse reactions such as hypersensitivity.
This recall does not involve any other lots of Tiger Snake Antivenom. |
| Instructions for Customers/Users |
Customers are to inspect stock and complete the acknowledgement form to organise replacement stock.
While waiting for the replacement stock to arrive, quarantine any units for the affected lot to prevent further use, unless required in an emergency scenario (and stock from an unaffected lot is not available).
Once replacement stock is received discard any remaining affected stock according to local destruction procedures.
This action was closed out on 5/9/2023. |
| Action Commencement Date |
7/06/2023 |
| Responsible Entity |
|
| Contact Information |
1800 642 865 - CSL Seqirus Medical Information |