FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg, 0.5mL suspension for injection, Sanofi Aventis Australia Pty Ltd, CON-331

European Pharmacopeia (01/20190158) - passage level of three of the working seed lots is beyond the limit indicated in the standard (0158). The test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen 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 batch is packaged in the Standard Export labelling (in Spanish and English), which does not conform with the requirements of TGO 91 on the following Paragraph 8(1)(d) the name of the dosage form (missing on carton) Paragraph 8(1)(i) the name and contact details of the sponsor (missing on carton) Subparagraph 8(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) Paragraph 9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe) Subsection 9(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) Paragraph 10(5)(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres (the trade name quot;FluQuadriquot; is less than 1.5 mm on syringe) Paragraph 11(1)(a) use of appropriate metric units (the abbreviation quot;mcgquot; is used rather than quot;microgramquot; in full on carton) Subsection 11(5) permitted statements of storage temperature conditions (quot;Store between +2ÌŠC to +8ÌŠC. Do not freezequot; is used rather than quot;Store at 2ÌŠC to 8ÌŠC Refrigerate. Do not freezequot; on carton).