Padmavati Pharmaceuticals · 99-39 · INDIA

Product code, Product and FDA notes

28 C - - 04 Basil (Sweet Basil), Natural Extract or Flavor (Spice) Date Published: 06/22/2017 Desc: Deltas Pancha Tulasi Drops Basils - 5 Notes: Section 403(y) of the Act in that the product label fails 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 address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares "solubiliser" along with other dietary ingredients, but this is not the common or usual name for an ingredient. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/22/2017 Desc: Deltas Pancha Tulasi Drops Basils - 5 Notes: Section 403(y) of the Act in that the product label fails 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 address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares "solubiliser" along with other dietary ingredients, but this is not the common or usual name for an ingredient.