# Botanicus, Spol S.R.O. · 66-41 · CZECH REPUBLIC — FDA import alert red lists: firms subject to detention without physical examination

For Botanicus, Spol S.R.O. · 66-41 · CZECH REPUBLIC, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CZECH REPUBLIC; product is Calendula Treatment Cream | Facial Regeneration Oil with Neroli Flower | Patchouli Hand Cream | Facial Regeneration Oil with Neroli Flower | Patchouli Hand Cream | Calendula Treatment Cream | Calendula Treatment Cream | Facial Regeneration Oil with Neroli Flower | Patchouli Hand Cream | Calendula Treatment Cream | Patchouli Hand Cream | Facial Regeneration Oil with Neroli Flower; product code is 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) | 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) | 53 B - - 01 Bath Oils, Tablets and Salts (Bath 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 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/11/2014; address is Ostra 8 289 22 Lysa , Nad Labem, CZECH REPUBLIC, verified against its source on 2026-09-16.

- **Firm:** Botanicus, Spol S.R.O. _(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:** CZECH REPUBLIC _(verified: appears in the quote below)_
- **Address:** Ostra 8 289 22 Lysa , Nad Labem, CZECH REPUBLIC _(verified: appears in the quote below)_
- **Date published:** 04/11/2014 _(verified: appears in the quote below)_
- **Product code:** 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) | 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) | 53 B - - 01 Bath Oils, Tablets and Salts (Bath 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 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 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:** Calendula Treatment Cream | Facial Regeneration Oil with Neroli Flower | Patchouli Hand Cream | Facial Regeneration Oil with Neroli Flower | Patchouli Hand Cream | Calendula Treatment Cream | Calendula Treatment Cream | Facial Regeneration Oil with Neroli Flower | Patchouli Hand Cream | Calendula Treatment Cream | Patchouli Hand Cream | Facial Regeneration Oil with Neroli Flower _(verified: each item appears in the quote below)_
- **FDA notes:** Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug | Problem -- Unapproved New Drug _(verified: each item appears in the quote below)_

## What the source says

> Botanicus, Spol S.R.O. Date Published : 04/11/2014 Ostra 8 289 22 Lysa , Nad Labem, CZECH REPUBLIC 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) Date Published: 04/11/2014 Desc: Calendula Treatment Cream Notes: Problem -- Unapproved New Drug 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) Date Published: 04/11/2014 Desc: Facial Regeneration Oil with Neroli Flower Notes: Problem -- Unapproved New Drug 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) Date Published: 04/11/2014 Desc: Patchouli Hand Cream Notes: Problem -- Unapproved New Drug 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/11/2014 Desc: Facial Regeneration Oil with Neroli Flower Notes: Problem -- Unapproved New Drug 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/11/2014 Desc: Patchouli Hand Cream Notes: Problem -- Unapproved New Drug 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/11/2014 Desc: Calendula Treatment Cream Notes: Problem -- Unapproved New Drug 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 04/11/2014 Desc: Calendula Treatment Cream Notes: Problem -- Unapproved New Drug 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 04/11/2014 Desc: Facial Regeneration Oil with Neroli Flower Notes: Problem -- Unapproved New Drug 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 04/11/2014 Desc: Patchouli Hand Cream Notes: Problem -- Unapproved New Drug 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/11/2014 Desc: Calendula Treatment Cream Notes: Problem -- Unapproved New Drug 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/11/2014 Desc: Patchouli Hand Cream Notes: Problem -- Unapproved New Drug 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/11/2014 Desc: Facial Regeneration Oil with Neroli Flower Notes: Problem -- Unapproved New Drug

## 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/).