| TGA Action ID |
RC-2026-RN-00652-1 |
| Type of Product |
Medicine |
| Product Name/Description |
MITOMYCIN OMEGAPHARM mitomycin powder for injection 20mg vial
Batch: P2600155
Exp 12/2027
HCL Material Code - 1159075
Symbion PDE - 047473 |
| ARTG Number |
243554 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a possibility that the product batch was exposed to conditions exceeding the recommended storage temperature during transit from the manufacturing site to the consignee's warehouse. Such exposure may have adversely affected the reconstitution characteristics of the product, leading to the quality discrepancy observed in the specific batch.
Market complaints have been received from two TGA-licensed Reconstitution facilities and two Hospitals, reporting that vials of MITOMYCIN OMEGAPHARM mitomycin powder for injection 20 mg vial - Batch P20600155 are not fully dissolving.
Complaint samples from Australian-held stock were tested. Investigations by the manufacturer, found that a temperature excursion occurred during air freight on the higher side, which may affect reconstitution characteristics.
To date, no adverse events have been reported or attributed to the presence of particles. Only part of Batch P20600155 appears to be affected, with some vials showing no problems. |
| Instructions for Customers/Users |
Customers are to:
- Return any affected stock on hand, together with the completed response form, via the wholesaler from whom the stock was purchased (Symbion or CH2).
- Obtain Mitomycin 20 mg from Baxter or Slade until replacement stock becomes available, anticipated in December 2026. |
| Action Commencement Date |
2/09/2026 |
| Responsible Entity |
|
| Contact Information |
03 9483 0070 - Mathew Wood, Omegapharm |