| TGA Action ID |
RC-2026-RN-00754-1 |
| Type of Product |
Medicine |
| Product Name/Description |
ELUCIREM Gadopiclenol Injection Solution Vials 7.5ml, 10ml and 50ml Vials and Prefilled Syringes 7.5ml and 10ml Syringes
Multiple batches and expiry dates
|
| ARTG Number |
444259, 444260, 444262, 444270, 444271 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
An error in the packaging of Elucirem was recently identified. Gadopiclenol quantity is expressed in “mg” instead of “g” on the carton and container labels; the quantities are correct, only the units are incorrect.
Guerbet Quality Assessment concluded that since the recommended dosage described in Elucirem Product Information (PI) is expressed in mL/kg body weight (BW), or equivalently in mmol/kg BW, specifically 0.1 mL/kg body weight (BW) (equivalent to 0.05 mmol/kg BW), the erroneous statement on the carton and container labels of Elucirem presentations is unlikely to have influenced healthcare professionals when determining the dose to be administered to the patient.
This error presents no impact on the product quality as it is limited to the text on the product’s labels only, and does not affect the manufacturing process, product composition, specifications, stability or product performance. |
| Instructions for Customers/Users |
Users should be aware of the labelling discrepancy and refer to the Product Information (pack insert) for the correct information.
The affected stock can still be used as normal, in accordance with the Product Information. |
| Action Commencement Date |
14/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 859 436 - Guerbet Customer Service |