| TGA Action ID |
RC-2026-RN-00771-1 |
| Type of Product |
Medicine |
| Product Name/Description |
FLUMAZENIL-BAXTER flumazenil 0.5 mg/5 mL solution for injection ampoule
Product Code: AIN00353
Lot Number: B5J0078A
Expiry Date: 02/2029 |
| ARTG Number |
231405 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
An Out-of-Specification (OOS) result for an impurity has been detected during 3-month stability testing. Subsequent investigation confirmed the presence of furosemide as an impurity in the affected lot. The affected product was distributed between 20th August 2026 to 10th September 2026 in Australia.
The impurity furosemide may lead to allergic reactions in those patients who receive the product and who are allergic to furosemide or sulfonamides. Allergic reactions may vary from minor problems such as itching/rash to more significant reactions, such as anaphylaxis.
To date, there have been no adverse events reported to Baxter related to this problem. |
| Instructions for Customers/Users |
Customers are to:
- Locate and return any unused affected product. The product code and lot number can be found on the individual product package labelling.
- For customers who received the communication directly from Baxter, they should return the response form, which will be forwarded to customer service to arrange for credit and return of the product.
- Alternatively, contact Baxter Customer Service to arrange for product return and replacement. |
| Action Commencement Date |
2/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 229 837 - Baxter Customer Service |