| TGA Action ID |
RC-2024-RN-00104-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Ultra Nature Selancy Women's 100 Blister Pack
Batch Numbers: 81032, 87908
Expiry Dates: 02/2026, 05/2026
ARTG 402035
(Ultra Nature Selancy Women) |
| ARTG Number |
402035 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
1.The primary pack contains more than the allowable 750mg of iron as per the specific requirements for iron (II) glycinate.
2. The Gelatin capsules may contain traces of sulfites or sulfur dioxide as a residue used as a preservative. Presence of sulfites in a medicine must be declared on the label of the medicine. The label does not include the statement ‘Contains sulfites’. However, a warning regarding sulfites is noted under the product description on the Ultra Nature website. |
| Instructions for Customers/Users |
Customers are advised to immediately inspect stock and quarantine any units from the affected batches. Return affected stock on hand to Selima Pharmaceuticals.
No alternative stock is available currently. Alternative stock is expected to be available from Selima Pharmaceuticals around May 2024 and stock will be available for order.
This action has been closed out on 29/05/2024 |
| Action Commencement Date |
14/02/2024 |
| Responsible Entity |
|
| Contact Information |
02 9644 9893 - Rena |