| TGA Action ID |
RC-2023-RN-00011-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Alfacalcidol Hexal 1 µg 50 and 100 soft capsules
All batches
Product is exempt from ARTG |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Medsurge Healthcare is recalling all batches of Alfacalcidol Hexal 1 µg 50 and 100 soft capsules for regulatory reasons and in connection with the AMK announcement of 19 December 2022. Further placing on the market is not permitted according to § 30 Para. 4 AMG since the suspension for the corresponding approvals was ordered. |
| Instructions for Customers/Users |
Medsurge Healthcare is advising customers to immediately examine inventory and quaratine any affected stock and discontinue use and distribution.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Action Commencement Date |
16/01/2023 |
| Responsible Entity |
|
| Contact Information |
1300 788 261 - Medsurge Healthcare |