Coles Zinc Plus (IVC Brunel Healthcare Pty Ltd)

The label was missing the mandatory warning statements that alert consumers about excess vitamin A exposure causing birth defects and the recommended daily intake of vitamin A. The warning statement related to use in pregnancy was missing a reference to the term ‘vitamin A’, was not in the correct location on the label and was inaccessible to consumers prior to purchase. The absence and incorrect placement of this information increases the risk of adverse outcomes for consumers, particularly women of childbearing age and individuals who are more susceptible to the toxic effects of vitamin A. The absence and incorrect placement of these warning statements is unacceptable, however, the probability of excess exposure to vitamin A as a result of this medicine is low and unlikely to pose an immediate risk to consumer health and safety.