FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60 mcg, 0.5 mL suspension for injection, Sanofi Aventis Australia Pty Ltd, CON-334

European Pharmacopeia (01/20190158) - Passage level of five of the working seed lots is beyond the limitindicated in the standard (0158). The test for Bacterial Endotoxins (2.6.14) and the assay of HaemagglutininAntigen by an immunodiffusion test (2.7.1) are not performed on the Final Lot. Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91) - The batchis packaged in the Standard Export labelling (in Spanish and English), which does not conform withtherequirements of the TGO 91 on the following paragraph8(1)(d) the name of the dosage form (missing on carton) paragraph8(1)(i) the name and contact details of the sponsor (missing on carton) subparagraph8(1)(j)(iv)(A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1 (statement regarding manufactured in eggs missing on carton) paragraph 9(1)(b) the name(s) of all active ingredients in the medicine (missing on syringe) paragraph9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe) subsection9(3) the name of the medicine and the name of active ingredients on the main label (they are placed separately as the same texts in Spanish are placed before English texts) paragraph10(5)(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres (the trade name 'FluQuadri' is less than 1.5 mm on syringe) paragraph11(1)(a) use of appropriate metric units (the abbreviation 'mcg' is used rather than 'microgram' in full on carton) subsection11(5) permitted statements of storage temperature conditions ('Store between +2ÌŠ C to +8ÌŠ C. Do not freeze' is used rather than 'Store at 2ÌŠ C to 8ÌŠ C' (Refrigerate. Do not freeze) on carton).