| TGA Action ID |
RC-2026-RN-00604-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Movicol Lemon & Lime 30s, Movicol Chocolate 30s, Movicol Junior Flavour Free 30s
Movicol Lemon & Lime 30s
Batch: 445603
EXP: 30 NOV 2027
Movicol Chocolate 30s
Batch:454784
EXP: 30 NOV 2027
Movicol Junior Flavour Free 30s
Batch: 478815
EXP: 30 SEP 2028 |
| ARTG Number |
60786, 160225, 181835 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class III |
| Reason for the Action |
Norgine conducted an investigation into MOVICOL products manufactured using the single-shot campaign filling process utilising residual bulk material which remains in the manufacturing line when an Intermediate Bulk Container (IBC) is changed. The investigation identified that in a limited number of batches the product has been manufactured with residual bulk material which was later deemed out-of-specification.
Norgine can confirm that there is no evidence of a patient safety or efficacy concern associated with this problem. A medical assessment of each out-of-specification blended bulk result concluded that the potential impact on patients would be negligible, taking into account the well-established efficacy and safety profile of macrogol 3350. |
| Instructions for Customers/Users |
Customers are to:
- Inspect inventory and take a photo of the affected stock on hand.
- Destroy the affected stock to prevent further use.
- Provide the photo evidence to Norgine for credit. |
| Action Commencement Date |
19/08/2026 |
| Responsible Entity |
|
| Contact Information |
contactanz@norgine.com - Norgine |