| TGA Action ID |
RC-2020-RN-00582-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil, Pastilles (soft gummies) 120's
120 pack size
Product code: 523254
Batches: 53666, 54907, 53338, 53099, 53664, 53089, 51928, 52969, 51927 and 51298
ARTG 313445 |
| ARTG Number |
313445 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class I |
| Reason for the Action |
Pharmacare are recalling multiple batches within expiry of Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil 120's, following a report of a serious allergic reaction to calcium sodium caseinate. The current label for this product does not declare the presence of milk products, but does list the presence of other allergens.
Due to the presence of milk products, this product poses a risk to children with a milk allergy and should not be consumed due to a risk of anaphylaxis.
Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil 60's currently includes milk as a declared allergen on the label, and thus the 60 pack is not affected by this recall.
Update 27/07/20 - Pharmacare are now performing a retail level recall (RC-2020-RN-00662-1) of multiple batches within expiry of Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil 60's, as given the shelf life it is possible that incorrectly labelled residual stock may remain on shelves with retailers of the 60 pack. |
| Instructions for Customers/Users |
PharmaCare are advising customers to quarantine all units from the affected batches, and complete the supplied acknowledgement form. PharmaCare are requesting customers identify in the acknowledgement form if stock will be returned or whether their organisation has disposed of affected stock. A credit note will be issued for impacted customers.
This action has been closed out on 24/11/2020 |
| Action Commencement Date |
3/07/2020 |
| Responsible Entity |
|
| Contact Information |
02 9997 0355 - PharmaCare Laboratories Pty Ltd |