OPTIRAY 320 Ioversol 135.6 g/200 mL injection vial, Guerbet Australia Pty Ltd, CON-940

​The products do not conform with the following requirements of subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) in that The vial outer carton labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the quantity of the medicine; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit. The vial (hanger) labels (for the AUST R 49423 and AUST R 49425 products) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name of the medicine and the name and quantity of the active ingredient as a cohesive unit; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect. The syringe outer carton labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include the Australian sponsor details; do not include a machine-readable code; do not include the name of the medicine on three non-opposing sides. The syringe labels and the syringe intermediate labels (for the AUST R 46642 product) do not include the approved name of dosage form; do not include the approved storage conditions (i.e., “Store below 25°C. Do not Freeze. Protect from light”); do not include a machine-readable code; do not include the name and quantity of the excipients; do not include the statement ‘Use in one patient on one occasion only’ or words to that effect.