ABRAXANE nanoparticle albumin-bound paclitaxel 100 mg powder for injection (suspension) vial, Abraxis Bioscience Australia Pty Ltd, CON-1094
Product name
ABRAXANE nanoparticle albumin-bound paclitaxel 100 mg powder for injection (suspension) vial
Sponsor name
Abraxis Bioscience Australia Pty Ltd
Batches
3A118B
Consent start
Consent no.
CON-1094
Standard
Paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply as the batch number and expiry date are not preceded
by the correct prefix on the vial label, as the batch number is preceded by the
date prefix and the date is preceded by the batch prefix.
Conditions imposed
A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 3 April 2023 will be supplied with each
affected batch warning that the batch number and expiry date are not preceded by
the correct prefix on the vial label, and therefore the vial must be stored in
the carton when not in use.
Therapeutic product type
Prescription medicines