Hill Pharmaceutical Co.,Ltd · 99-39 · CHINA
For Hill Pharmaceutical Co.,Ltd · 99-39 · CHINA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is CHINA; product is Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) | Ultimate Immortals Er Zhi Xian Fang (Herbal dietary supplement) | Ultimate Immortals Er Zhi Xian Fang (Herbal dietary supplement) | Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement); product code is 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C; date published is 03/31/2025; 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
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- CHINA verified
- Address
- 128 Taoyuan West Road , Lengshuitan District , Yongzhou, Hunan CHINA verified
- Date published
- 03/31/2025 verified
- Product code
- 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. each item verified
- Product
- Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) | Ultimate Immortals Er Zhi Xian Fang (Herbal dietary supplement) | Ultimate Immortals Er Zhi Xian Fang (Herbal dietary supplement) | Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name “Glycyrrhiza uralensis”, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,000mg must be expressed as 1g) 921 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name Triticum aestivum, but it does not list “Wheat”, i.e., the Standardized Common Name (SCN) given in the reference Herbs of Commerce. The product label lists the Latin binomial name Glycyrrhiza uralensis, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 10000 units must be declared in the next higher set of units, e.g., 10,000mg must be expressed as 10g), (21 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name Triticum aestivum, but it does not list “Wheat”, i.e., the Standardized Common Name (SCN) given in the reference Herbs of Commerce. The product label lists the Latin binomial name Glycyrrhiza uralensis, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 10000 units must be declared in the next higher set of units, e.g., 10,000mg must be expressed as 10g), (21 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name “Glycyrrhiza uralensis”, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,000mg must be expressed as 1g) 921 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages. each item verified
What the source says
Hill Pharmaceutical Co.,Ltd Date Published : 03/31/2025 128 Taoyuan West Road , Lengshuitan District , Yongzhou, Hunan CHINA 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 03/31/2025 Desc: Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name “Glycyrrhiza uralensis”, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,000mg must be expressed as 1g) 921 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages. 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 04/04/2025 Desc: Ultimate Immortals Er Zhi Xian Fang (Herbal dietary supplement) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name Triticum aestivum, but it does not list “Wheat”, i.e., the Standardized Common Name (SCN) given in the reference Herbs of Commerce. The product label lists the Latin binomial name Glycyrrhiza uralensis, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 10000 units must be declared in the next higher set of units, e.g., 10,000mg must be expressed as 10g), (21 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/04/2025 Desc: Ultimate Immortals Er Zhi Xian Fang (Herbal dietary supplement) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name Triticum aestivum, but it does not list “Wheat”, i.e., the Standardized Common Name (SCN) given in the reference Herbs of Commerce. The product label lists the Latin binomial name Glycyrrhiza uralensis, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 10000 units must be declared in the next higher set of units, e.g., 10,000mg must be expressed as 10g), (21 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/31/2025 Desc: Aller Ease Bi Qiu Tang Jia Jian (Herbal dietary supplement) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Food, Drug, and Cosmetic Act (the Act). Product label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). The product label lists the Latin binomial name “Glycyrrhiza uralensis”, but it does not list the SCN given in the reference Herbs of Commerce. Section 403(q) of the Act. Nutrition information on the labeling does not comply with 21 CFR 101.36. Quantitative amount by weight per serving of the proprietary blends does not use metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,000mg must be expressed as 1g) 921 CFR 101.36(b)(3)(ii)(A)). Section 403(f) of the Act. Label contains information in two languages but does not repeat all required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The label contains information in two languages but does not repeat all required information in both languages.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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