| TGA Action ID |
RC-2026-RN-00635-1 |
| Type of Product |
Medicine |
| Product Name/Description |
MEDICIANZ MUPIROCIN OINTMENT Mupirocin 2%w/w Tube
Lot Numbers: S082414.2, S092415.1, S092416.1
Expiry Dates: 08/2026, 09/2026 |
| ARTG Number |
279471 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
During ongoing stability testing, an out of specification (OOS) result was obtained for the stability batch (Batch No. S062409.1) at the 24-month testing point for both the assay (content) of Mupirocin and related impurities.
Following initial evaluation, the affected batches have been identified as those manufactured within a defined period between June 2024 and September 2024. The event is traceable to a single root cause associated with a specific excipient batch used temporarily during that timeframe.
All subsequent batches fall outside the scope of this recall investigation and are not affected.
Based on the preliminary assessment, no risk to patients is expected, as the concerned batches are close to their expiry date, and the probability of the affected product being used for treatment is therefore very low. |
| Instructions for Customers/Users |
Customers should inspect their stock immediately and quarantine affected stock of product MUPIROCIN OINTMENT, batch number S082414.2, S092415.1 and S092416.1, on hand to prevent further use.
Depending on the quantity of the affected product with customers, customers will be instructed to either destroy the product and provide a destruction certificate or return the affected product to Medsurge. |
| Action Commencement Date |
18/08/2026 |
| Responsible Entity |
|
| Contact Information |
1300 788 261 or customerservice@medsurgehc.com |