RIKODEINE 9.5 mg/5 mL oral liquid bottle, iNova Pharmaceuticals (Australia) Pty Limited, CON-868
Product name
RIKODEINE 9.5 mg/5 mL oral liquid bottle
Sponsor name
iNova Pharmaceuticals (Australia) Pty Limited
Batches
100ml pack size: batches 1092659, 1094828, 1094653, 1099003, 1105307 and 1106191. 200ml pack size: batches 1092292, 1091236, 1092658, 1094204, 1093782, 1094825, 1094827, 1094826, 1099004, 1099005, 1099006, 1099563, 1103712, 1104697, 1104696, 1105306, 1105859, 1106193, 1106192 and 1108040.
Consent start
Consent no.
CON-868
Standard
Subparagraph 11(1)(a)(v) of Therapeutic Goods Order No. 92 '“ Standard for labels of non-prescription medicines
Non-compliance with standard
The product does not conform to the requirements of subparagraph 11(1)(a)(v) of
Therapeutic Goods Order No. 92 '“ Standard for labels of non-prescription
medicines in that under the heading 'Active ingredients per 10 mL', the labels
incorrectly state the quantity of sorbitol as '4.4 mg' when the correct unit of
measure is '4.4 g'.
Therapeutic product type
Over-the-counter medicines