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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01054-1
Product Name/Description	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 ARTG 276929 (Galderma Australia Pty Ltd - Sculptra Poly-L-lactic acid - Dermal tissue reconstructive material, synthetic polymer)
Recall Action Level	Retail
Recall Action Classification	Class III
Recall Action Commencement Date	14/12/2023
Responsible Entity	NaN
Reason/Issue	Galderma 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.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers 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. This action has been closed out on 15/4/2024.
Contact Information	medinfoau@galderma.com