DBL CYTARABINE 1 g/10 mL injection vial, Pfizer Australia Pty Ltd, CON-768

The product does not conform to the requirements of paragraphs 8(1)(i), 8(1)(o), 9(1)(d), 9(3)(a), 10(3)(a); and subsection 9(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the product packaging does not comply with the following the name and address of the current Australian sponsor are not included on the carton and vial labelsthe name of the medicine is not on at least three non-opposing sides of the cartonthe approved name of the dosage form is not included on the carton and the vialthe name and quantity of the active ingredient are not placed together on one line immediately below the name of the medicine on the main labelthe name and quantity of the excipients '“ sodium hydroxide and hydrochloric acid are not included on the cartonthe name of the active ingredient on the main label has a text height of less than 3.0 millimetres.