DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. · 66-41 · CROATIA
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
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- CROATIA verified
- Address
- Production site: Sveta Nedjelja , Headquarters: Vijenac Frane Gotovca 8 , Zagreb-slobostina, Grad Zagreb CROATIA verified
- Date published
- 02/09/2024 verified
- 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 each item verified
- 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 each item verified
- 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. each item verified
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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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