HPS Pharmacies wish to advise that Janssen-Cilag, in consultation with the Therapeutic Goods Administration (TGA), has issued a product correction for all strenghts of Invega Sustenna®, Invega Trinza®, Invega Hafyera® pre-filled syringes, as follows:
- Invega Sustenna®: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg
- Invega Trinza®: 175 mg, 263 mg, 350 mg, 525 mg
- Invega Hafyera®: 700 mg in 3.5 mL, 1000 mg in 5 mL
Issue:
A packaging defect affecting the needle blister cover was identified at a very low rate (~0.0035%). This defect may compromise needle sterility. No related complaints have been reported in Australia.
The manufacturer has completed a thorough investigation and implemented enhanced quality control measures, including additional manual visual inspections at multiple stages of the packaging process, to prevent recurrence.
Affected batches:
Batches of Invega Sustenna®, Invega Trinza®, Invega Hafyera® expiring up to September 2027 may be affected. Batches expiring October 2027 or later are not impacted.
Actions:
Healthcare professionals are advised to:
- Visually inspect the needle blister before administration of Invega Sustenna®, Invega Trinza®, Invega Hafyera® with an expiry date up to and including September 2027.
- Do not use the supplied needle if the blister shows visible damage, perforations, or any signs that its integrity may be compromised.
- Quarantine any affected units for return and replacement.
Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Janssen-Cilag on 1800 226 334, or your pharmacist at HPS Pharmacies.
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