Apicola de Allende, S.A. de C.V. · 99-39 · MEXICO

Product code, Product and FDA notes

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/24/2017 Desc: Royal Jelly Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. The product appears to be misbranded within the meaning of section 403(q)(1)(B) because the label fails to declare the servings per container in accordance with 21CFR 101.36(b)(1)(ii). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/24/2017 Desc: Royal Jelly Capsules Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/24/2017 Desc: Propolis Liquid Extract Drops Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/24/2017 Desc: Propolis Capsules Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/24/2017 Desc: Bee Pollen Notes: The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of 403(r)(2)(A) of the Act [21U.S.C. § 343 (r)(2)(A)] because the label makes a claim stating the absence of a nutrient which is not in accordance with 21CFR 101.13(e)(2). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/24/2017 Desc: EspectiBron Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36.