Wroclawskie Zaklady Zielarskie Herbapol S.A. · 99-39 · POLAND

Product code, Product and FDA notes

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/10/2015 Desc: Radirex (Rhubarb root extract) Notes: The product is misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the label or labeling of the dietary supplement fails to identify the product by using the term "dietary supplement"; or an appropriately descriptive term indicating the type of dietary ingredients that are in the product on the principal display panel as required by 21 CFR 101.3 (g). The product is misbranded within the meaning of section 403(y) [21 U.S.C. 343 (y)] of the Act because the label fails to bear a domestic address or domestic phone number through which the responsible person; as described in section 761 [21 U.S.C. 379aa-1] of the Act; may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1) (A) of the Act [21 U.S.C. §343(q)(1)(A)]. Published on 07/14/2015 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/10/2015 Desc: Radirex (Rhubarb root extract) Notes: The product is misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the label or labeling of the dietary supplement fails to identify the product by using the term "dietary supplement"; or an appropriately descriptive term indicating the type of dietary ingredients that are in the product on the principal display panel as required by 21 CFR 101.3 (g). The product is misbranded within the meaning of section 403(y) [21 U.S.C. 343 (y)] of the Act because the label fails to bear a domestic address or domestic phone number through which the responsible person; as described in section 761 [21 U.S.C. 379aa-1] of the Act; may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1) (A) of the Act [21 U.S.C. §343(q)(1)(A)]. Published on 07/14/2015 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/10/2015 Desc: Radirex (Rhubarb root extract) Notes: The product is misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the label or labeling of the dietary supplement fails to identify the product by using the term "dietary supplement"; or an appropriately descriptive term indicating the type of dietary ingredients that are in the product on the principal display panel as required by 21 CFR 101.3 (g). The product is misbranded within the meaning of section 403(y) [21 U.S.C. 343 (y)] of the Act because the label fails to bear a domestic address or domestic phone number through which the responsible person; as described in section 761 [21 U.S.C. 379aa-1] of the Act; may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1) (A) of the Act [21 U.S.C. §343(q)(1)(A)].