Famar Health Care Services Madrid S.A. · 66-41 · SPAIN
For Famar Health Care Services Madrid S.A., import alert is 66-41; country is SPAIN; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- Firm
- Famar Health Care Services Madrid S.A. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- SPAIN verified
- Address
- Avenida Leganes 62 , Alcorcon, Madrid SPAIN verified
- Date published
- 06/30/2025 verified
- Product code
- 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Essentiale N | Essentiale N each item verified
- 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)]. each item verified
What the source says
Famar Health Care Services Madrid S.A. Date Published : 06/30/2025 Avenida Leganes 62 , Alcorcon, Madrid SPAIN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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)].
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html