Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posed a medical device safety alert concerning Teoxane S.A. Teosyal Puresense Redensity I [Batch numbers: 22191EL1, 23061CL0, 23201CL1] [HKMD No.: 170175].

According to the TGA, one box of Teosyal Puresense Redensity I was identified with missing information on the carton. The errors on the outer box include:

• The manufacturer name in the upper left part of the box (Teoxane) is missing.
• Incorrect mention of the product brand name in the centre of the box, it reads ‘Redensity 1’ instead of ‘Teosyal Redensity 1.’
• The words 'Puresense' and 'Hyaluronic acid + lidocaine' are missing from the bottom left of the box.
• No syringe size on the front of the box.
• The words 'with lidocaine' are missing from the bottom of the box.

For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00879-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 13 Oct 2023