# DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. · 66-41 · CROATIA — FDA import alert red lists: firms subject to detention without physical examination

For DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. · 66-41 · CROATIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CROATIA; product is LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | LENTIFORM DIETARY SUPPLEMENT 100% PURE 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 - - 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. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 02/09/2024; 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:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **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:** 02/09/2024 _(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 - - 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. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs _(verified: each item appears in the quote below)_
- **Product:** LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM | AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT | LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. | The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. _(verified: each item appears in the quote below)_

## What the source says

> DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. Date Published : 02/09/2024 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: 02/09/2024 Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. Date Published: 02/09/2024 Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C. Date Published: 02/09/2024 Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/09/2024 Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/09/2024 Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/09/2024 Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 02/09/2024 Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 02/09/2024 Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 02/09/2024 Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 66 - - - -- Human and Animal Drugs Date Published: 02/09/2024 Desc: AGARIKON 1 DIETARY SUPPLEMENT 100% PURE MUSHROOM Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 66 - - - -- Human and Animal Drugs Date Published: 02/09/2024 Desc: AGARIKON PLUS DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs. 66 - - - -- Human and Animal Drugs Date Published: 02/09/2024 Desc: LENTIFORM DIETARY SUPPLEMENT 100% PURE MUSHROOM EXTRACT Notes: The product appears to be an unapproved new drug, because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Statements in product labeling provide evidence of the intended use of the products as drugs.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.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/).