| TGA Action ID |
RC-2024-RN-00550-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Potassium Iodide (Vitamatic) 65 mg tablets x60
Batch: M0669
Expiry: 03/2025
Supplied via SAS Pathway |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Orspec Pharma has received a report of confusion due to the product labelling. The total content of the Potassium Iodide is noted on the front label as 65mg, and the serving size is presented as 2 tablets which equals 65mg.
There is a potential for the patients to be under treated if they believe the actual tablet dosage in the bottle is 65mg instead of 32.5mg. |
| Instructions for Customers/Users |
· Immediately identify and quarantine the affected units in inventory.
· Once the customer acknowledge form is returned, customers will be contacted by a Representative to arrange for a product return.
· Ensure a copy of the Notification of Urgent Medicine Recall Letter is displayed in a prominent area.
This action has been finalised on 3/10/2024. |
| Action Commencement Date |
3/07/2024 |
| Responsible Entity |
|
| Contact Information |
02 4339 4239 - Michelle Pruis |