The Therapeutic Goods Administration (TGA) has issued an urgent product defect correction for:
ENDONE oxycodone hydrochloride 5mg tablet blister pack
Batch Number: CW612
Expiry: Nov 2020
AUST R: 14945
SPONSOR: Aspen Pharma Pty Ltd
PHONE: 1300 659 656 – Aspen Medical Information
REASON: A single report has been received from a consumer in South Australia indicating that a strip of 30mg Anamorph tablets was allegedly present in a box of 5mg Endone, post dispensing.
The Anamorph tablets are approximately four times the Endone equivalent dose, so there is a theoretical potential for overdose, particularly if taken by an opioid naïve patient.
This action supersedes the quarantine notice issued 26 July 2019.
PROPOSED CUSTOMER ACTIONS: This action supersedes the retail level quarantine notice issued 26 July 2019.
Actions for Pharmacists:
Pharmacists are requested to visually inspect the blisters in Endone boxes (batch CW612), prior to dispensing the tablets to patients
Actions for Consumers:
Prior to use, patients are requested to visually inspect the blisters in the boxes to verify both blister strips are Endone tablets.
In the event customers identify a blister with ‘Anamorph’ printed on the back, or any other anomaly, do not use tablets from that strip.
Return any incorrect tablets to the place of purchase.
Further information is available on the TGA website at:
The sponsor is expected to dispatch letters to all affected customers within two working days of the agreement date (27/07/2019)