BUSULFEX busulfan 60 mg/10 mL injection vial, Otsuka Australia Pharmaceutical Pty Ltd, CON-726
Product name
BUSULFEX busulfan 60 mg/10 mL injection vial
Sponsor name
Otsuka Australia Pharmaceutical Pty Ltd
Batches
All batches manufactured and released for supply before 6 February 2022
Consent start
Consent no.
CON-726
Standard
Paragraphs 10(2)(a), 8(1)(a), 9(1)(a), 9(1)(g), 9(3)(b), 9(1)(d), 8(1)(d), 8(1)(i), 7(2)(d), 10(4)(d), and subsection 9(5) of Therapeutic Goods Order No. 91
Non-compliance with standard
The product(s) vial label does not conform to the requirements of Therapeutic
Goods Order No. 91, paragraphs 10(2)(a), 8(1)(a), 9(1)(a), 9(1)(g), 9(3)(b),
9(1)(d), 8(1)(d), 8(1)(i), 7(2)(d), 10(4)(d), and subsection 9(5), in that the
product(s) vial label is the US label and does not contain Australia-specific
information. Specifically, the vial label is missing the correct AAN for
Macrogol 400 (instead states quot;polyethylene glycol-400 quot;), name of the
medicine includes quot;IV quot; in front of quot;Busulfex quot;, missing
quot;for infusion quot;, name of active ingredient is in brackets, missing name
of dosage form, missing Australian sponsor and contact details, text size is too
small for name of active ingredient, the quantity or proportion of active
ingredient in the medicine, quantity of the medicine, name of
sponsor/distributor, approved route of administration.
Conditions imposed
The vial label is the US vial label provided in the letter dated 02
December 2020.
The US Product Information (PI) will be removed from the cartons
containing the single vial and the Australian approved PI will be included
inside the outer carton containing the 8 single vial cartons.
Arrangements are in place with the stated Distributor on the vial label
(Otsuka America Pharmaceutical, Inc), for the prompt referral of any queries or
complaints concerning the products to Otsuka Australia Pharmaceutical Pty Ltd
(the current sponsor).
Therapeutic product type
Prescription medicines