| TGA Action ID |
RC-2020-RN-00662-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Nature’s Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil, Pastilles (soft gummies) 60’s
60 pack size
Product Code: 523225
Affected Batches:
(B) 50676 EXP 10/2021
(B) 50668 EXP 04/2021
(B) 51222 EXP 10/2021
(B) 50238 EXP 04/2021
(B) 50718 EXP 08/2021
(B) 28722A EXP 02/2021
(B) 50342 EXP 06/2021
(B) 28721A EXP 02/2021
(B) 50675 EXP 04/2021
ARTG 313445 |
| ARTG Number |
313445 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class I |
| Reason for the Action |
PharmaCare Laboratories are recalling multiple batches within expiry of Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil 60's, following a report of a serious allergic reaction to calcium sodium caseinate. The current label for the affected batches 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.
PharmaCare already corrected this labelling anomaly in November 2019 and all stock manufactured from that date includes the warning. However, given the shelf life, it is possible that incorrectly labelled residual stock may remain on shelves with retailers.
This action is in addition to the recent recall action RC-2020-RN-00582-1, which was for multiple batches of the 120 pack size of the product for the same labelling defect. |
| Instructions for Customers/Users |
PharmaCare are advising customers to quarantine all units from the affected batches, and complete the supplied acknowledgement form. After returning the form, PharmaCare requests customers destroy the affected stock, and a credit note will be issued.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Action Commencement Date |
27/07/2020 |
| Responsible Entity |
|
| Contact Information |
02 9997 0355 - PharmaCare Laboratories Pty Ltd |