Urgent product defect correction– ENDONE - Notice from the Therapeutic Goods Administration
Urgent product defect correction– Notice from the TGA - ENDONE oxycodone hydrochloride 5mg tablet blister pack
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.
This action supersedes the retail level quarantine notice issued 26 July 2019.
Further information is available on the TGA website at: https://www.tga.gov.au/alert/endone-5-mg-tablets