TUBERSOL tuberculin purified protein derivative (mantoux) diagnostic antigen vial , Sanofi-Aventis Australia Pty Ltd, CON-1415

The product labels do not conform because: • The Australian Approved Name for the active ingredient is ‘Tuberculin PPD’. The label expresses the active ingredient as 'Tuberculin purified protein derivative'. • The name of the dosage form ‘Injection, solution’ is missing from the labels. • The Australian Approved Name for the active ingredient is ‘Tuberculin PPD’, however the label expresses the active ingredient as 'Tuberculin purified protein derivative' on the main label instead. • The dosage form ‘Injection, solution’ is not included on the main label. • The name of the medicine and the name and quantity of the medicine do not appear as a cohesive unit. The name of the active ingredient and the quantity of the active ingredient are disrupted by '(Montoux) Test dose:'. • The text size for the name and quantity of the active ingredient is 2.6 mm, which is smaller than the minimum 3 mm required by TGO 91. • Not all excipients are listed on the carton label. • The label of the primary pack is non-compliant. • The container label does not specify the stated volume of fill. • The approved storage condition text is ‘Store at 2°C to 8°C (Refrigerate. Do not freeze)’. The word ‘refrigerate’ is missing from the label.