Safety Information Regarding Possible Use of Counterfeit Biostimulator “Sculptra” New
The Federal Office for Safety in Health Care (BASG) has been informed that the following products are circulating as counterfeits:
- Sculptra, Lot No.: A00203 Expiry: 04/04/2027
- Sculptra, Lot No.: A6108 Expiry: 12/2026
According to the manufacturer, the counterfeit can be identified by the following features:
- Batch number and expiry date
The mentioned products are counterfeits. These products were not manufactured or distributed by the legal manufacturer Q-Med AB, a company based in Sweden.
Description of the potential issue:
There is a potential health risk, as the safety and efficacy of the counterfeit products are not guaranteed. The contents of the counterfeit products are unknown.
Actions to be taken by users:
In case a counterfeit product has been obtained, users are requested to take the following steps:
- Do not use the product
- Immediately isolate the product in a secure location so it is available for possible investigation
- Please forward all information regarding the counterfeit product (photos, details about the quantity, contact details of the supplier from whom the counterfeit product was obtained, …) to BASG (medizinprodukte@basg.gv.at) and the legal manufacturer Q-Med AB (complaints.q-med@galderma.com)
Due to current events, the Federal Office for Safety in Health Care (BASG) issues the following warning:
- Counterfeit medical devices have no or unpredictable effects and must be considered dangerous. They must not be used under any circumstances.
- It cannot be ruled out that counterfeit products of this type are present on the Austrian market.
- BASG strongly recommends obtaining medical devices exclusively through trusted distribution channels.
| Medical devices | Sculptra |
|---|---|
| Manufacturer | Q-Med AB |
| Batch number(s) | Lot No.: A00203 Expiration date: 04/04/2027 Lot No.: A6108 Expiration date: 12/2026 |
