| TGA Action ID |
RC-2026-RN-00752-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fibrase (Pentosan) 100 mg/mL Injection (pack of 10 ampoules)
Lot numbers: G250800 and G248874
Supplied via SAS |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Foreign particulate matter was detected in two batches of Fibrase 100mg/mL injection.
Because Fibrase is administered intramuscularly or intravenously, injected particles may cause a local inflammatory reaction at the administration site. If particles enter the circulation, they may occlude small blood vessels and cause localised tissue injury or granuloma formation. |
| Instructions for Customers/Users |
Customers are to immediately inspect stock and quarantine all affected Fibrase (Pentosan) 100 mg/mL Injection (pack of 10 ampoules), lot numbers G250800 and G248874, to prevent further use.
Following receipt of a completed response form, Medsurge will provide information to customers regarding return/destruction of stock. |
| Action Commencement Date |
29/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 788 261 - Medsurge Healthcare |