Hill Pharmaceutical Co.,Ltd · 66-41 · CHINA
For Hill Pharmaceutical Co.,Ltd · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product is Xiao Chai Hu Tang He Si Wu Tang Jia Jian Capsules | Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) | Xiao Chai Hu Tang He Si Wu Tang Jia Jian Capsules; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 03/24/2025; address is 128 Taoyuan West Road , Lengshuitan District , Yongzhou, Hunan CHINA, verified against its source on 2026-09-16.
- Firm
- Hill 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
- CHINA verified
- Address
- 128 Taoyuan West Road , Lengshuitan District , Yongzhou, Hunan CHINA verified
- Date published
- 03/24/2025 verified
- Product code
- 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Xiao Chai Hu Tang He Si Wu Tang Jia Jian Capsules | Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) | Xiao Chai Hu Tang He Si Wu Tang Jia Jian Capsules each item verified
- FDA notes
- Article appears to be subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. The implied disease claim noted on the firm’s labeling for the product is evidence that the product is intended for use as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. verified
What the source says
Hill Pharmaceutical Co.,Ltd Date Published : 03/24/2025 128 Taoyuan West Road , Lengshuitan District , Yongzhou, Hunan CHINA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/24/2025 Desc: Xiao Chai Hu Tang He Si Wu Tang Jia Jian Capsules 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/01/2025 Desc: Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) Notes: Article appears to be subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. The implied disease claim noted on the firm’s labeling for the product is evidence that the product is intended for use as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/24/2025 Desc: Xiao Chai Hu Tang He Si Wu Tang Jia Jian Capsules
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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