# AMDERMIK SL · 66-41 · SPAIN — FDA import alert red lists: firms subject to detention without physical examination

For AMDERMIK SL · 66-41 · SPAIN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SPAIN; product is World Dermic MesoLipo | World Dermic PeptiDermic | H-100 Bio-Revitalisation | World Dermic Ampelopsin | H-50 Bio-Revitalisation | World Dermic MesoHair | World Dermic MesoLipo | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic MesoHair | World Dermic PeptiDermic | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic PeptiDermic | World Dermic MesoLipo | World Dermic MesoHair | H-50 Bio-Revitalisation; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/24/2024; address is Calle De Pablo Iglesias 63 Pl , Mataro, Barcelona SPAIN, verified against its source on 2026-09-16.

- **Firm:** AMDERMIK SL _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** SPAIN _(verified: appears in the quote below)_
- **Address:** Calle De Pablo Iglesias 63 Pl , Mataro, Barcelona SPAIN _(verified: appears in the quote below)_
- **Date published:** 04/24/2024 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** World Dermic MesoLipo | World Dermic PeptiDermic | H-100 Bio-Revitalisation | World Dermic Ampelopsin | H-50 Bio-Revitalisation | World Dermic MesoHair | World Dermic MesoLipo | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic MesoHair | World Dermic PeptiDermic | H-50 Bio-Revitalisation | H-100 Bio-Revitalisation | World Dermic Ampelopsin | World Dermic PeptiDermic | World Dermic MesoLipo | World Dermic MesoHair | H-50 Bio-Revitalisation _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.' | The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.' _(also on this page, in the second passage quoted below)_

## What the source says

> AMDERMIK SL Date Published : 04/24/2024 Calle De Pablo Iglesias 63 Pl , Mataro, Barcelona SPAIN 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic MesoLipo 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic PeptiDermic 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: H-100 Bio-Revitalisation 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic Ampelopsin 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: H-50 Bio-Revitalisation 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2024 Desc: World Dermic MesoHair 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic MesoLipo 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: H-100 Bio-Revitalisation 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic Ampelopsin 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic MesoHair 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: World Dermic PeptiDermic 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/24/2024 Desc: H-50 Bio-Revitalisation 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: H-100 Bio-Revitalisation 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic Ampelopsin 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic PeptiDermic 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic MesoLipo 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: World Dermic MesoHair 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2024 Desc: H-50 Bio-Revitalisation

## The same source also states

> Amdermik Sl Date Published : 03/09/2017 Avinguda Cabrera 36 , Mataro, Barcelona SPAIN 53 L - - -- Skin Care Prep Date Published: 03/09/2017 Desc: Hyaluronidase Notes: The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.' 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/09/2017 Desc: Hyaluronidase Notes: The product appears to be an unapproved new drug as the product website includes claims such as: 'The active hyaluronidase for virtual mesotherapy is essential for the elimination of liquids and to reduce the volume of adipocytes; Hyaluronidase is an enzyme that hydrolyzes hyaluronic acid (HA), promoting the diffusion of fluids in the tissues and facilitating their absorption; It also increases the action of the local anesthetic, prevents the risk of necrosis in sclerotherapy, and has fibrinolytic action.'

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).