| TGA Action ID |
RC-2024-RN-00727-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cisatracurium Accord (as besilate) 10 mg/5 mL solution for injection vial
Batch number: M2216786
Manufacturing date: December 2022
Expiry date: November 2024
ARTG 222405 |
| ARTG Number |
222405 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Cis-Monoacrylate impurity in CISATRACURIUM ACCORD Cisatracurium (as besilate) 10 mg/5 mL solution for injection vial, batch M2216786 exceeded the impurity limit of NMT 2.5% at the 18-month stability timepoint. This problem was reported by the manufacturer after routine testing of stability samples. |
| Instructions for Customers/Users |
Customers are to:
- Inspect stock and quarantine products from the affected batch, then destroy stock per protocol and forward a destruction certificate to Accord Healthcare.
If wholesalers have sold the product on to additional customers, they should advise Accord Healthcare of additional customers affected by the recall.
This action has been finalised on 25/11/2024. |
| Action Commencement Date |
30/08/2024 |
| Responsible Entity |
|
| Contact Information |
1800 222 673 - Accord Healthcare |