DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. · 99-39 · CROATIA

For DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. · 99-39 · CROATIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is CROATIA; product is Lentifom Mushroom Extract | Myko San Agarikon.1 Medicinal Mushroom Supplement | Myko San Agarikon Plus Mushroom Extract | Lentifom Mushroom Extract | Myko San Agarikon Plus Mushroom Extract | Myko San Agarikon.1 Medicinal Mushroom Supplement | Myko San Agarikon.1 Medicinal Mushroom Supplement | Lentifom Mushroom Extract | Myko San Agarikon Plus Mushroom Extract; product code is 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. | 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. | 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 19 Egg Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 05/21/2024; address is Production site: Sveta Nedjelja , Headquarters: Vijenac Frane Gotovca 8 , Zagreb-slobostina, Grad Zagreb CROATIA, verified against its source on 2026-09-16.

What the source says

DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. Date Published : 05/21/2024 Production site: Sveta Nedjelja , Headquarters: Vijenac Frane Gotovca 8 , Zagreb-slobostina, Grad Zagreb CROATIA 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. Date Published: 05/21/2024 Desc: Lentifom Mushroom Extract Notes: 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: Sections 403(e)(1), 403(e)(2), 403(i)(2), 403(q)(5)(F), 403(y), and 403(s)(2)(B) of the FD&C Act. Product (outer box labels, and inner glass container label) does not bear the name and place of business of the manufacturer, packer, or distributor; 2) the net contents; 3) the common or usual name of each ingredient; 4) nutrition information; 5) the statement of identity of the product; and 6) a domestic address or phone number through which the responsible person, as described in section 761 [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplement. Each of the inner product labels is exempt from sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act [21 U.S.C. 343(e)(2), 343(i)(2), 343(q)(5)(F)] if each label bears the statement “This Unit Not Labeled For Retail Sale” [21 CFR 1.24(a)(14)]. Section 403(f) of the FD&C Act. Product labels contain information in two languages but do not repeat all required information in both languages. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The outer box labels contain information in two languages, but do not repeat all required information in both languages. 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. Date Published: 05/21/2024 Desc: Myko San Agarikon.1 Medicinal Mushroom Supplement Notes: 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(e)(1) of the FD&C Act. Label does not bear the address for the manufacturer (21 CFR 101.5); specifically, the postal code is missing. Section 403(y) of the FD&C Act. Label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. Date Published: 05/21/2024 Desc: Myko San Agarikon Plus Mushroom Extract Notes: 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: Sections 403(e)(1), 403(e)(2), 403(i)(2), 403(q)(5)(F), 403(y), and 403(s)(2)(B) of the FD&C Act. Product (outer box labels, and inner glass container label) does not bear the name and place of business of the manufacturer, packer, or distributor; 2) the net contents; 3) the common or usual name of each ingredient; 4) nutrition information; 5) the statement of identity of the product; and 6) a domestic address or phone number through which the responsible person, as described in section 761 [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplement. Each of the inner product labels is exempt from sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act [21 U.S.C. 343(e)(2), 343(i)(2), 343(q)(5)(F)] if each label bears the statement “This Unit Not Labeled For Retail Sale” [21 CFR 1.24(a)(14)]. Section 403(f) of the FD&C Act. Product labels contain information in two languages but do not repeat all required information in both languages. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The outer box labels contain information in two languages, but do not repeat all required information in both languages. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 05/21/2024 Desc: Lentifom Mushroom Extract Notes: 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: Sections 403(e)(1), 403(e)(2), 403(i)(2), 403(q)(5)(F), 403(y), and 403(s)(2)(B) of the FD&C Act. Product (outer box labels, and inner glass container label) does not bear the name and place of business of the manufacturer, packer, or distributor; 2) the net contents; 3) the common or usual name of each ingredient; 4) nutrition information; 5) the statement of identity of the product; and 6) a domestic address or phone number through which the responsible person, as described in section 761 [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplement. Each of the inner product labels is exempt from sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act [21 U.S.C. 343(e)(2), 343(i)(2), 343(q)(5)(F)] if each label bears the statement “This Unit Not Labeled For Retail Sale” [21 CFR 1.24(a)(14)]. Section 403(f) of the FD&C Act. Product labels contain information in two languages but do not repeat all required information in both languages. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The outer box labels contain information in two languages, but do not repeat all required information in both languages. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 05/21/2024 Desc: Myko San Agarikon Plus Mushroom Extract Notes: 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: Sections 403(e)(1), 403(e)(2), 403(i)(2), 403(q)(5)(F), 403(y), and 403(s)(2)(B) of the FD&C Act. Product (outer box labels, and inner glass container label) does not bear the name and place of business of the manufacturer, packer, or distributor; 2) the net contents; 3) the common or usual name of each ingredient; 4) nutrition information; 5) the statement of identity of the product; and 6) a domestic address or phone number through which the responsible person, as described in section 761 [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplement. Each of the inner product labels is exempt from sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act [21 U.S.C. 343(e)(2), 343(i)(2), 343(q)(5)(F)] if each label bears the statement “This Unit Not Labeled For Retail Sale” [21 CFR 1.24(a)(14)]. Section 403(f) of the FD&C Act. Product labels contain information in two languages but do not repeat all required information in both languages. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The outer box labels contain information in two languages, but do not repeat all required information in both languages. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 05/21/2024 Desc: Myko San Agarikon.1 Medicinal Mushroom Supplement Notes: 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(e)(1) of the FD&C Act. Label does not bear the address for the manufacturer (21 CFR 101.5); specifically, the postal code is missing. Section 403(y) of the FD&C Act. Label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 19 Egg Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 05/21/2024 Desc: Myko San Agarikon.1 Medicinal Mushroom Supplement Notes: 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(e)(1) of the FD&C Act. Label does not bear the address for the manufacturer (21 CFR 101.5); specifically, the postal code is missing. Section 403(y) of the FD&C Act. Label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/21/2024 Desc: Lentifom Mushroom Extract Notes: 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: Sections 403(e)(1), 403(e)(2), 403(i)(2), 403(q)(5)(F), 403(y), and 403(s)(2)(B) of the FD&C Act. Product (outer box labels, and inner glass container label) does not bear the name and place of business of the manufacturer, packer, or distributor; 2) the net contents; 3) the common or usual name of each ingredient; 4) nutrition information; 5) the statement of identity of the product; and 6) a domestic address or phone number through which the responsible person, as described in section 761 [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplement. Each of the inner product labels is exempt from sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act [21 U.S.C. 343(e)(2), 343(i)(2), 343(q)(5)(F)] if each label bears the statement “This Unit Not Labeled For Retail Sale” [21 CFR 1.24(a)(14)]. Section 403(f) of the FD&C Act. Product labels contain information in two languages but do not repeat all required information in both languages. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The outer box labels contain information in two languages, but do not repeat all required information in both languages. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/21/2024 Desc: Myko San Agarikon Plus Mushroom Extract Notes: 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: Sections 403(e)(1), 403(e)(2), 403(i)(2), 403(q)(5)(F), 403(y), and 403(s)(2)(B) of the FD&C Act. Product (outer box labels, and inner glass container label) does not bear the name and place of business of the manufacturer, packer, or distributor; 2) the net contents; 3) the common or usual name of each ingredient; 4) nutrition information; 5) the statement of identity of the product; and 6) a domestic address or phone number through which the responsible person, as described in section 761 [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplement. Each of the inner product labels is exempt from sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act [21 U.S.C. 343(e)(2), 343(i)(2), 343(q)(5)(F)] if each label bears the statement “This Unit Not Labeled For Retail Sale” [21 CFR 1.24(a)(14)]. Section 403(f) of the FD&C Act. Product labels contain information in two languages but do not repeat all required information in both languages. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The outer box labels contain information in two languages, but do not repeat all required information in both languages.

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.