Update 3 - Infringement notices issued
9 October 2020
Following further investigation, the TGA has issued 13 infringement notices totalling $164,520 to Pharmacare in relation to the advertising of this, and another related, medicine. The infringement notices relate to the alleged omission of milk products from the ingredient warning present on the label and web pages for these medicines.
Update 2 - Recall expanded
30 July 2020
In consultation with the TGA, Pharmacare is now also recalling nine batches of the 60 pastille pack size with an expiry date up to and including 10/2021 (October 2021) from retail stores.
This action follows a consumer complaint which identified a number of bottles of the 60 pastille pack size that did not include milk as a declared allergen on the label. Subsequently, the TGA has confirmed that not all of the currently available stock in the 60 pack size declares milk as an allergen on the product label.
The TGA reiterates that both the 60 and 120 pastille pack size of Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445) are not suitable for consumers with a milk allergy as it contains milk products.
Further information on the recall can be found in the System for Australian Recall Actions.
9 July 2020
Following further investigation, Pharmacare, in consultation with the TGA, is recalling all affected batches of the 120 pastille pack size from retail stores. This issue does not affect the 60 pastille pack size which currently includes milk as a declared allergen on the label. Further information on the recall can be found in the System for Australian Recall Actions.
Safety advisory – Contains undeclared milk products
25 June 2020
Consumers and health professionals are advised that Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445) contain milk products. The current label for this product does not declare the presence of milk products, but does list the presence of other allergens.
The Therapeutic Goods Administration (TGA) became aware of this issue following a report of a serious allergic reaction. Following our investigation, the product's sponsor, Pharmacare, introduced an updated label to warn consumers that the product contains milk products. Pharmacare has also updated the information on the website related to this product.
Further information on labelling requirements for medicines containing allergens can be found on the Allergies and medicines page of the TGA website.
Information for consumers
Please be aware that this product contains milk products. This product should not be consumed by individuals with a milk allergy.
If you suspect you have had an adverse effect to this product, please report it to the TGA.
Information for health professionals
Please be aware of the above issue and advise patients accordingly if they seek advice.
If you have any questions or concerns about this issue, contact Pharmacare on 02 9997 1466.
Consumers and health professionals are encouraged to report problems with medicines or vaccines Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.