# Hill Pharmaceutical Co.,Ltd · 66-41 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** 128 Taoyuan West Road , Lengshuitan District , Yongzhou, Hunan CHINA _(verified: appears in the quote below)_
- **Date published:** 03/24/2025 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).