# DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. · 99-39 · CROATIA — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** CROATIA _(verified: appears in the quote below)_
- **Address:** Production site: Sveta Nedjelja , Headquarters: Vijenac Frane Gotovca 8 , Zagreb-slobostina, Grad Zagreb CROATIA _(verified: appears in the quote below)_
- **Date published:** 05/21/2024 _(verified: appears in the quote below)_
- **Product code:** 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. _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_
- **FDA 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. _(verified: each item appears in the quote below)_

## 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.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).