Reference Source

Totra Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)

For Totra Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is Brown Rice Moisture Shampoo | Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) | Suwall Luxury Oriental Shampoo | Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Animal Cutie Mask Pack Relaxing Charcoal and Aloe | Animal Cutie Mask Pack Relaxing Charcoal and Aloe | Suwall Luxury Oriental Shampoo | Animal Cutie Mask Pack Relaxing Charcoal and Aloe | Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) | Brown Rice Moisture Shampoo; product code is 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 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; date published is 04/24/2017; address is 248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
Totra Co., Ltd. verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
KOREA (THE REPUBLIC OF) verified
Address
248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) verified
Date published
04/24/2017 verified
Product code
53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 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. each item verified
Product
Brown Rice Moisture Shampoo | Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) | Suwall Luxury Oriental Shampoo | Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Animal Cutie Mask Pack Relaxing Charcoal and Aloe | Animal Cutie Mask Pack Relaxing Charcoal and Aloe | Suwall Luxury Oriental Shampoo | Animal Cutie Mask Pack Relaxing Charcoal and Aloe | Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) | Brown Rice Moisture Shampoo each item verified
FDA notes
The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' | Totra Co. Ltd. is the OASIS declared manufacturer. | Drug claims made on product labels and company websites. | Totra Co. Ltd. is the OASIS declared manufacturer. | Drug claims made on product labels and company websites. | The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' | Structure and function claims made on product labels | Structure and function claims made on product labels | Drug claims made on product labels and company websites. | Structure and function claims made on product labels | Totra Co. Ltd. is the OASIS declared manufacturer. | The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' 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

Totra Co., Ltd. Date Published : 04/24/2017 248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 04/24/2017 Desc: Brown Rice Moisture Shampoo Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 04/24/2017 Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) Notes: Totra Co. Ltd. is the OASIS declared manufacturer. 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 05/09/2017 Desc: Suwall Luxury Oriental Shampoo Notes: Drug claims made on product labels and company websites. 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 04/24/2017 Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) Notes: Totra Co. Ltd. is the OASIS declared manufacturer. 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 05/09/2017 Desc: Suwall Luxury Oriental Shampoo Notes: Drug claims made on product labels and company websites. 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 04/24/2017 Desc: Brown Rice Moisture Shampoo Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 04/24/2017 Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe Notes: Structure and function claims made on product labels 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/13/2019 Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe Notes: Structure and function claims made on product labels 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/09/2017 Desc: Suwall Luxury Oriental Shampoo Notes: Drug claims made on product labels and company websites. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2017 Desc: Animal Cutie Mask Pack Relaxing Charcoal and Aloe Notes: Structure and function claims made on product labels 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2017 Desc: Amore Shampoo Set (Ryo Anti-Hair Loss Shampoo and Treatment) Notes: Totra Co. Ltd. is the OASIS declared manufacturer. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2017 Desc: Brown Rice Moisture Shampoo Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.'

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

Source

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