| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-01557-1 |
| Product Name/Description |
Fu Gui Ba Wei Tang a.k.a. Rehmannia Eight Vitality Formula & Nuan Gong Cheng Yun Fang a.k.a. Motherhood 1 Formula
All batches
AUST L 148050 and 199691 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2022 |
| Responsible Entity |
|
| Reason/Issue |
Sun Herbal is recalling Fu Gui Ba Wei Tang a.k.a. Rehmannia Eight Vitality Formula and Nuan Gong Cheng Yun Fang a.k.a. Motherhood 1 Formula due to missing warning statements on the label of the medicine.
These two products contain fennel as an active ingredient and are subsequently required to carry the mandatory safety contraindication warnings below.
- ‘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’.
These products may pose an unacceptable risk of harm to pregnant women, breast-fed infants and young children and therefore should not be taken by them. |
| Recall Action |
Recall |
| Recall Action Instructions |
Sun Herbal is advising all customers to immediately inspect their stock and quarantine all the affected stock on hand to prevent further use. All affected product should be returned to Sun Herbal with a completed inventory form.
In the event that affected stock has been transferred from one location to another, inform the other location of this recall by providing a copy of the customer letter and advise them to contact the sponsor to return the product. Practitioners should contact any patients who have been provided this product.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0409 429 078 - Tony Reid |