Rohto Pharmaceutical Co., Ltd. · 66-41 · JAPAN
For Rohto Pharmaceutical Co., Ltd. · 66-41 · JAPAN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is JAPAN; product is Melano CC Brightening Milk | Melano CC Brightening Milk; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 07/17/2025; address is Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN, verified against its source on 2026-09-16.
- Firm
- Rohto Pharmaceutical Co., Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- JAPAN verified
- Address
- Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN verified
- Date published
- 07/17/2025 verified
- Product code
- 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Melano CC Brightening Milk | Melano CC Brightening Milk 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
Rohto Pharmaceutical Co., Ltd. Date Published : 07/17/2025 Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 07/17/2025 Desc: Melano CC Brightening Milk 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: 07/17/2025 Desc: Melano CC Brightening Milk 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)].
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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