Product Defect Correction

Further to DrugAlert Volume 481, HPS Pharmacies wish to advise that Aspen Pharma, in consultation with the Therapeutic Goods Administration (TGA), have given updated advice on the drug quarantine for Endone^® as follows:

Endone^® Tablets
Oxycodone hydrochloride 5mg
ARTG 14945

The only batch affected by this notice is CW612 with an expiry date of November 2020.

The contents of all boxes from the affected batch should be visually inspected prior to dispensing to patients or supplying to wards. Healthcare professionals and patients are also advised to inspect the blisters in the boxes prior to administration to confirm that both blisters in the Endone^® box contain Endone^® tablets. If any anomaly is detected, the tablets must not be used.

This product defect correction has been initiated following a single consumer report alleging that a strip of Anamorph^® tablets was present in a box of Endone^® 5mg tablets. Each Anamorph^® tablet contains 30mg of morphine sulfate which is approximately four times the equivalent dose of an Endone^® tablet. Therefore, there is a theoretical potential for overdose or adverse effects.

Please inspect your stock and quarantine all affected products. 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 Aspen Pharma on 1300 659 646.