| TGA Action ID |
RC-2026-RN-00751-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Buprenorphine Hydrochloride 0.3 mg/mL Injection (Pack of 5 x 1 mL Vials)
Lot Numbers: 84234, 85003, 86443, 89646
Supplied via SAS |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is the potential presence of white, crystalline particulates in certain lots. The particulates are understood to be comprised of the drug product formulation, principally buprenorphine free base.
Particulate matter, if administered by injection, may cause localised irritation and inflammation at the injection site and blockage of small blood vessels, with potential for localised tissue damage or granuloma formation.
|
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock immediately and quarantine any stock of the affected batches on hand to prevent further use.
- Depending on the quantity of the affected product and after confirmation from the supplier, they will either be instructed to destroy the product and provide a destruction certificate or return the affected product to Medsurge. |
| Action Commencement Date |
28/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 788 261 - Medsurge Healthcare |