DIANEAL 1mmol Calcium in 2.5% Glucose Peritoneal dialysis solution freeline Solo Twin Bag AHB8238, Baxter HealthcarePty Ltd, CON-550

The products that do not conform to the requirements of paragraphs 9(3)(a) and 9(3)(b) of Therapeutic Goods Order 91 with respect to the following paragraphs 8(1)(b) and 8(1)(n) - the label refers to the previous Australian Approved Name (AAN) for glucose (monohydrate) and does not contain a machine readable code;paragraphs 9(3)(a) and 9(3)(b) - the label does not include the name of the medicine and the name of the actives and their quantities as a cohesive unit that is not separated by text or graphics; subsection 9(6) - the label does not meet text size requirementsparagraphs 10(8)(b), 10(8)(e) and 10(8)(f) - the label provides an approximate osmolality value rather than milliosmoles per litre, does not include the statement 'Not to be used for Intravenous infusion' (has 'For intraperitoneal administration only' instead) and does not contain the statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative' (includes 'single dose' and 'sterile').