BUSULFEX busulfan 60 mg/10 mL injection vial, Otsuka Australia Pharmaceutical Pty Ltd, CON-528

The product's vial labels do not meet the following requirements of Therapeutic Goods Order No. 91 Paragraph 10(2)(a) name of the excipient is not the Australian Approved Name (AAN) - Macrogol 400. Instead states 'polyethylene glycol-400'.Paragraphs 8(1)(a) 9(1)(a) Name of the medicine includes IV in front of 'Busulfex' Paragraph 9(1)(g) Missing 'for infusion' adjacent to name of the medicine Paragraph 9(3)(b) Active ingredient includes brackets (separated from tradename by text) Paragraphs 8(1)(e), 9(1)(e) 10(3)(a)(i) Quantity or proportion of active expressed as per mL instead of quantity in medicine (i.e. 6 mg/mL instead of 60 mg/10 mL) Paragraphs 9(1)(d) 8(1)(d) Missing name of dosage form Paragraph 8(1)(i) Missing Australian sponsor or distributor details Paragraphs 7(2)(d), 10(4)(d) subsection 9(5) 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.