| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-01392-1 |
| Product Name/Description |
Detox + Debloat
Batch Numbers: B23434, B23441, B23462, B23463, B23485, B211091, B211111, B211161, B211231, B211341.
Expiry Date Range: November 2022 to March 2024
ARTG 309600 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/11/2022 |
| Responsible Entity |
|
| Reason/Issue |
JSHealth Vitamins is recalling 10 batches of its Detox + Debloat tablets (AUST L 309600) because the medicine label doesn’t include the below necessary warning statements:
- ‘Use in children under 12 years is not recommended’;
- ‘Do not use if pregnant or likely to become pregnant (or words to that effect)’; and
- ‘Do not use while breastfeeding’
Detox + Debloat includes an extract of Foeniculum vulgare (fennel) seeds. There is a chemical component in fennel seeds that may not be safe for pregnant or breast-feeding women and is not recommended for children under 12 years of age.
All batches with an expiry date after March 2024 contain the appropriate warnings and are not impacted by this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
CONSUMERS:
a) Consumer customers should return their affected bottle to the place of purchase to receive a refund.
b) If purchased online, consumer customers should visit "www.danddrecall.com.au" to receive a refund.
RETAILERS:
a) Immediately quarantine unsold impacted product and remove them from your shelves.
b) Follow instructions within the JSHealth Vitamins customer letter to appropriately process consumer returns and refunds. All consumer returned product shoud be recorded appropriately and destroyed on site.
c) Follow instructions within the JSHealth Vitamins customer letter for return and refund of unsold product.
WHOLESALERS:
a) Immediately quarantine unsold impacted product and remove them from your shelves.
b) Follow instructions within the JSHealth Vitamins customer letter for return and refund of unsold product.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0405 802 877 - JSHealth Vitamins dedicated recall number. |