| TGA Action ID |
RC-2026-RN-00156-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fentanyl GH Solution for Injection 500 microgram/10 mL
Batch Number: 40679
Expiry Date: October 2027 |
| ARTG Number |
201871 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There has been one market complaint regarding a single ampoule of Fentanyl 500mcg/10mL lot 40679 that was found damaged within a sealed blister. There was a hole in the tip of the ampoule with small amount of liquid in the blister casing.
Investigation performed by Panpharma determined that the fully automatic leak testing machine contributed to the formation of this defect. The defect can be clearly identified. However, a residual risk of fragile ampoule heads with poorly visible damage cannot be fully excluded. A compromised container-closure has a potential risk of microbial ingress, affecting the sterility of the product.
No patient harm has been reported due to this problem. |
| Instructions for Customers/Users |
Customers are to:
- Inspect each ampoule carefully prior to administration.
- Do not use any ampoules that show signs of tip damage, cracking or any structural irregularity. |
| Action Commencement Date |
6/03/2026 |
| Responsible Entity |
|
| Contact Information |
03 9809 7900 - Generic Health |