Wroclawskie Zaklady Zielarskie Herbapol S.A. · 99-39 · POLAND
For Wroclawskie Zaklady Zielarskie Herbapol S.A. · 99-39 · POLAND, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is POLAND; product is Radirex (Rhubarb root extract) | Radirex (Rhubarb root extract) | Radirex (Rhubarb root extract); product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 07/10/2015; address is Ul. Swietego Mikolaja 65/68 , Wroclaw, Dolnoslaskie POLAND, verified against its source on 2026-09-16.
- Firm
- Wroclawskie Zaklady Zielarskie Herbapol S.A. verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- POLAND verified
- Address
- Ul. Swietego Mikolaja 65/68 , Wroclaw, Dolnoslaskie POLAND verified
- Date published
- 07/10/2015 verified
- Product code
- 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Radirex (Rhubarb root extract) | Radirex (Rhubarb root extract) | Radirex (Rhubarb root extract) each item verified
- FDA 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 | 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 | 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)]. each item verified
What the source says
Wroclawskie Zaklady Zielarskie Herbapol S.A. Date Published : 07/10/2015 Ul. Swietego Mikolaja 65/68 , Wroclaw, Dolnoslaskie POLAND 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)].
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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