Reference Source

Botanicus, Spol S.R.O. · 66-41 · CZECH REPUBLIC

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
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
CZECH REPUBLIC verified
Address
Ostra 8 289 22 Lysa , Nad Labem, CZECH REPUBLIC verified
Date published
04/11/2014 verified
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. each item verified
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 each item verified
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 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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