Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Q-Med AB Sculptra Poly L Lactic Acid Vials 150mg Powder for Injection [Batch Number: 3J1983, 3J3366, 3J3574, 3J2421; Expiry Dates: 31/03/2026, 03/06/2026, 30/06/2026, 30/04/2026] [HKMD No.: 170085].
According to the TGA, the manufacturer has changed the approved intended use for Sculptra by removing the indication for use in scars and restricting the use of Sculptra to areas of the face. Affected users are advised that there has been a change to the IFU, reflecting restriction of usage to the face and the removal of scars as an indication. The electronic IFU has also been amended.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-01054-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Dec 2023