Product Defect Correction
HPS Pharmacies wish to advise that Janssen-Cilag, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect correction for Jurnista® as follows:
Jurnista® Prolonged Release Tablets
Hydromorphone hydrochloride 8mg
The only batch affected by this issue is IALS400 with an expiry date of December 2019.
This product defect correction has been initiated due to reports of damage to the tablets as a result of a misalignment issue with the packaging machine. Damage to the outer coating of Jurnista® tablets may alter the release rate of the active ingredient, potentially resulting in overdose or lack of steady-state condition due to more rapid absorption. Alternatively, degradation of the active ingredient may occur due to oxygen exposure, potentially leading to drug under-dosing.
There is no quality issue with tablets that have not been physically damaged. Please inspect your stock and only quarantine packets containing damaged tablets. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.
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 your pharmacist at HPS Pharmacies, or Janssen-Cilag on 1800 226 334.