GLIADEL WAFER carmustine 7.7 mg/implant implant sachet, Eisai Australia Pty Ltd, CON-627

The product that does not conform to the requirements of the Therapeutic Goods Order No. 91, in that the components of the product labelling do not meet Outer carton label8(1)(o) - the name of the medicine does not appear on at least three non opposing sides of the carton9(3)(a) - the name of the medicine and the names of the active ingredients on the main label do not appear as a cohesive unit11(5)(i) - the permitted statements of storage temperature conditions are not described as required (store below '“18°C (Deep freeze)Outer foil pouch9(3)(f) - the name of the sponsor or distributor, or a registered trademark, is not present11(5)(i) - the permitted statements of storage temperature conditions are not described as required (Store below '“18°C (Deep freeze))Inner foil pouch does not state 10(13)(a)(v) - the name of the medicine10(13)(a)(vi) - the name(s) of all active ingredients in the medicine10(13)(a)(vii) - the quantity or proportion of all active ingredients in the medicine10(13)(a)(viii) - the batch number of the medicine preceded by the batch number prefix10(13)(a)(ix) - the expiry date of the medicine preceded by the expiry date prefix10(13)(a)(x) - the name of the sponsor or distributor, or registered rademark