# Famar Health Care Services Madrid S.A. · 66-41 · SPAIN — FDA import alert red lists: firms subject to detention without physical examination

For Famar Health Care Services Madrid S.A. · 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 Essentiale N | Essentiale N; product code is 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/30/2025; address is Avenida Leganes 62 , Alcorcon, Madrid SPAIN, verified against its source on 2026-09-16.

- **Firm:** Famar Health Care Services Madrid S.A. _(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:** Avenida Leganes 62 , Alcorcon, Madrid SPAIN _(verified: appears in the quote below)_
- **Date published:** 06/30/2025 _(verified: appears in the quote below)_
- **Product code:** 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Essentiale N | Essentiale N _(verified: each item appears in the quote below)_
- **FDA notes:** Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. _(verified: each item appears in the quote below)_

## What the source says

> Famar Health Care Services Madrid S.A. Date Published : 06/30/2025 Avenida Leganes 62 , Alcorcon, Madrid SPAIN 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 06/30/2025 Desc: Essentiale N Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/30/2025 Desc: Essentiale N Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].

## 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/).