Hill Pharmaceutical Co.,Ltd · 66-41 · CHINA
For Hill Pharmaceutical Co.,Ltd, import alert is 66-41; country is CHINA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html