Counterfeit "Sculptra Batch 5J0406 with expiry date 26/05/2028" New
The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Sculptra" from the manufacturer "Q-Med AB".
It cannot be ruled out that this counterfeit is also on the Austrian market. Counterfeit medical devices are technically unsafe or have no or an unpredictable effect or function and are therefore to be classified as dangerous. They must not be used under any circumstances.
The counterfeit is an imitation of the legitimate product SculptraTM. The legitimate SculptraTM is an implant made of poly-L-lactic acid.
According to the manufacturer of the legitimate product, the counterfeits can be recognised by the following characteristic: Batch 5J0406, expiry date 26/05/2028
There is a potential health risk, as the function, safety and efficacy of counterfeit medical devices are not given or cannot be assessed. Counterfeit medical devices are not manufactured in accordance with the quality standards and legal requirements applicable to legitimate original products. They have an unknown origin. Q-Med AB is not the manufacturer of the counterfeit product and therefore not responsible for it.
The BASG asks you to report any suspicious observations in connection with the above-mentioned products by e-mail to the BASG (medizinprodukte@basg.gv.at) and the manufacturer (contact person: pharmakovigilanz.austria@galderma.com ).
| Medical devices | Counterfeit to be mistaken for Sculptra |
|---|---|
| Manufacturer | unknown |
| Batch number(s) | 5J0406 |
