| TGA Action ID |
RC-2026-RN-00831-1 |
| Type of Product |
Medicine |
| Product Name/Description |
INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA paliperidone (as palmitate) modified release suspension for injection pre-filled syringe
INVEGA SUSTENNA 100 mg, 150 mg, 25 mg, 50 mg, 75 mg
INVEGA TRINZA 175 mg, 263 mg, 350 mg, 525 mg
INVEGA HAFYERA 1000 mg in 5 mL, 700 mg in 3.5 mL
Expiry: Up to and including Sep 2027 |
| ARTG Number |
160856, 160857, 160858, 160859, 160860, 261332, 261406, 261407, 261408, 354080, 354090 |
| Action Type |
Product Correction |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
During packaging activities, units with damage to the needle blister cover were detected. Damage or perforation to the cover foil of the needle blister may compromise the sterility of the enclosed needle. This could potentially result in local or systemic infection.
No complaints related to this defect have been received in Australia to date. |
| Instructions for Customers/Users |
Healthcare professionals are to:
- Visually inspect the needle blister before administration.
- If the blister shows visible damage, perforations or signs that its integrity may be compromised, do not administer the product with that needle and contact the sponsor to return the product. |
| Action Commencement Date |
28/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 226 334 - Janssen-Cilag Customer Service |