TECHNELITE Molybdenum(99Mo)/Technetium(99mTc) sterile Generator for production of Sodium pertechnetate(99mTc) injection multidose vial, Global Medical Solutions Australia Pty Limited, CON-714

The product(s) do not conform to the requirements of paragraphs 8(1)(b), 8(1)(i), 8(1)(n), 9(1)(b), 9(3)(a) and subsection 9(4) of Therapeutic Goods Order No. 91, in that the required information in the main label and vial labels is absent [name of medicine and active as a cohesive unit], text on the main label is not in the same orientation, the active ingredients are not stated using the Australian Approved Names, a machine readable code is absent, and the name and current address of the sponsor is not stated.