Lanzhou Foci Pharmaceutical Co., Ltd. · 99-39 · CHINA

Product code, Product and FDA notes

54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Bao He Teapills (Bao He Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Xiang Sha Yang Wei Wan (Digestive Aid) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Xiao Chai HuTang Wan (Liver Smooth) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Bao He Wan (Strengthen Digestion) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Huo Xiang Zheng Qi Wan (Strengthen Dampness) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Xiang Sha Liu Jun Wan (Digestion Ease) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Clear Mountain Air Teapills (Ding Chuan Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Xiang Sha Yang Wei Wan Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Major Bupleurum Teapills (Da Chai Hu Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 A - - 99 Vitamin, N.E.C. Date Published: 07/10/2025 Desc: Huo Xiang Zheng Qi Teapills (Huo Xiang Zheng Qi Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Bao He Teapills (Bao He Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Huo Xiang Zheng Qi Teapills (Huo Xiang Zheng Qi Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Major Bupleurum Teapills (Da Chai Hu Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Xiang Sha Yang Wei Wan Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Clear Mountain Air Teapills (Ding Chuan Wan) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Xiang Sha Liu Jun Wan (Digestion Ease) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Huo Xiang Zheng Qi Wan (Strengthen Dampness) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Bao He Wan (Strengthen Digestion) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Xiao Chai HuTang Wan (Liver Smooth) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2025 Desc: Xiang Sha Yang Wei Wan (Digestive Aid) Notes: products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. products are misbranded within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h).