| TGA Action ID |
RC-2020-RN-00551-1 |
| Type of Product |
Medicine |
| Product Name/Description |
GOLD CROSS Potassium Permanganate Powder 50g
All Batches
ARTG 27378
(GOLD CROSS POTASSIUM PERMANGANATE powder) |
| ARTG Number |
27378 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
Investigations by iNova have found that all batches of Gold Cross Potassium Permanganate supplied to the market are not packaged with a child resistant cap, which is required under Therapeutic Goods Order 95.
This packaging omission is unlikely to be readily identifiable by customers. There is a potential risk that children may access product and accidentally ingest.
To date, there have been no reports of adverse events related to this issue, either in currently available batches, or to the best of the sponsor's knowledge in previously supplied batches. |
| Instructions for Customers/Users |
Retail pharmacies are advised to immediately quarantine impacted product and return to the wholesaler for a refund.
Wholesalers are advised to immediately quarantine all units of Gold Cross Potassium Permanganate to prevent further distribution. iNova Pharmaceuticals will contact all impacted wholesalers to organise the destruction of affected stock.
This action has been closed out on 05/01/2021 |
| Action Commencement Date |
9/07/2020 |
| Responsible Entity |
|
| Contact Information |
1800 630 056 - iNova Pharmaceuticals Customer Service |